Trial Outcomes & Findings for A Phase 1b/2 Study of OMP-59R5 (Tarextumab) in Combination With Nab-Paclitaxel and Gemcitabine in Subjects With Previously Untreated Stage IV Pancreatic Cancer (NCT NCT01647828)

Last Updated: 2023-02-15

Results Overview

Number of participants with dose-limiting toxicities when administered OMP-59R5 every of other week (Days 1 and 15) in combination with nab-paclitaxel (Nab-P) 125 mg/m2 and gemcitabine (Gem) 1000 mg/m2 on Days 1, 8, and 15 of every 28-day cycle in subjects with previously untreated stage IV pancreatic cancer. In the event that no DLTs are observed, maximum tested dose would be considered the Maximum Tolerated Dose (MTD).

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

217 participants

Primary outcome timeframe

Up to 1 year in absence of unacceptable toxicity or disease progression.

Results posted on

2023-02-15

Participant Flow

Phase 1b: A total of 40 subjects were planned and enrolled. Phase 2: Approximately 160 subjects were planned to be randomized. A total of 177 subjects were enrolled/randomized. Total: 217 subjects were enrolled/randomized (Phase 1b and Phase 2)

Participant milestones

Participant milestones
Measure	P1B: OMP-59R5 2.5 mg/kg + Gem Cohort 1: Subjects receive OMP-59R5 2.5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	P1B: OMP-59R5 5 mg/kg + Gem Cohort 2: Subjects receive OMP-59R5 5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	P1B: OMP-59R5 5 mg/kg + Nab-P + Gem Cohort 3: Subjects receive OMP-59R5 5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	P1B: OMP-59R5 7.5 mg/kg + Nab-P + Gem Cohort 4: Subjects receive OMP-59R5 7.5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	P1B: OMP-59R5 10 mg/kg + Nab-P + Gem Cohort 5: Subjects receive OMP-59R5 10 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	P1B: OMP-59R5 12.5 mg/kg + Nab-P + Gem Cohort 6: Subjects receive OMP-59R5 12.5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	P1B: OMP-59R5 15 mg/kg + Nab-P + Gem Expansion Cohort: Subjects receive OMP-59R5 15 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	P2: Placebo + Nab-P + Gem Placebo Arm: Subjects receive placebo (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	P2: OMP-59R5 15 mg/kg + Nab-P + Gem Active Arm: Subjects receive OMP-59R5 15 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).
Overall Study STARTED	5	4	4	6	6	3	12	88	89
Overall Study COMPLETED	0	0	0	0	0	0	0	0	0
Overall Study NOT COMPLETED	5	4	4	6	6	3	12	88	89

Reasons for withdrawal

Reasons for withdrawal
Measure	P1B: OMP-59R5 2.5 mg/kg + Gem Cohort 1: Subjects receive OMP-59R5 2.5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	P1B: OMP-59R5 5 mg/kg + Gem Cohort 2: Subjects receive OMP-59R5 5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	P1B: OMP-59R5 5 mg/kg + Nab-P + Gem Cohort 3: Subjects receive OMP-59R5 5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	P1B: OMP-59R5 7.5 mg/kg + Nab-P + Gem Cohort 4: Subjects receive OMP-59R5 7.5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	P1B: OMP-59R5 10 mg/kg + Nab-P + Gem Cohort 5: Subjects receive OMP-59R5 10 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	P1B: OMP-59R5 12.5 mg/kg + Nab-P + Gem Cohort 6: Subjects receive OMP-59R5 12.5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	P1B: OMP-59R5 15 mg/kg + Nab-P + Gem Expansion Cohort: Subjects receive OMP-59R5 15 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	P2: Placebo + Nab-P + Gem Placebo Arm: Subjects receive placebo (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	P2: OMP-59R5 15 mg/kg + Nab-P + Gem Active Arm: Subjects receive OMP-59R5 15 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).
Overall Study Death	3	4	4	5	6	3	10	60	71
Overall Study Withdrawal by Subject	2	0	0	1	0	0	1	0	2
Overall Study Study terminated by Sponsor	0	0	0	0	0	0	1	26	16
Overall Study Lost to Follow-up	0	0	0	0	0	0	0	2	0

Baseline Characteristics

A Phase 1b/2 Study of OMP-59R5 (Tarextumab) in Combination With Nab-Paclitaxel and Gemcitabine in Subjects With Previously Untreated Stage IV Pancreatic Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	P1B: OMP-59R5 2.5 mg/kg + Gem n=5 Participants Cohort 1: Subjects receive OMP-59R5 2.5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	P1B: OMP-59R5 5 mg/kg + Gem n=4 Participants Cohort 2: Subjects receive OMP-59R5 5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	P1B: OMP-59R5 5 mg/kg + Nab-P + Gem n=4 Participants Cohort 3: Subjects receive OMP-59R5 5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	P1B: OMP-59R5 7.5 mg/kg + Nab-P + Gem n=6 Participants Cohort 4: Subjects receive OMP-59R5 7.5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	P1B: OMP-59R5 10 mg/kg + Nab-P + Gem n=6 Participants Cohort 5: Subjects receive OMP-59R5 10 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	P1B: OMP-59R5 12.5 mg/kg + Nab-P + Gem n=3 Participants Cohort 6: Subjects receive OMP-59R5 12.5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	P1B: OMP-59R5 15 mg/kg + Nab-P + Gem n=12 Participants Expansion Cohort: Subjects receive OMP-59R5 15 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	P2: Placebo + Nab-P + Gem n=88 Participants Placebo Arm: Subjects receive placebo (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	P2: OMP-59R5 15 mg/kg + Nab-P + Gem n=89 Participants Active Arm: Subjects receive OMP-59R5 15 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	Total n=217 Participants Total of all reporting groups
Age, Customized Age	66 years n=5 Participants	68 years n=7 Participants	68 years n=5 Participants	66 years n=4 Participants	67 years n=21 Participants	58 years n=10 Participants	59 years n=115 Participants	66 years n=6 Participants	66 years n=6 Participants	66 years n=64 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=10 Participants	4 Participants n=115 Participants	34 Participants n=6 Participants	39 Participants n=6 Participants	91 Participants n=64 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	0 Participants n=10 Participants	8 Participants n=115 Participants	54 Participants n=6 Participants	50 Participants n=6 Participants	126 Participants n=64 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	5 Participants n=6 Participants	1 Participants n=6 Participants	10 Participants n=64 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	6 Participants n=4 Participants	6 Participants n=21 Participants	3 Participants n=10 Participants	11 Participants n=115 Participants	81 Participants n=6 Participants	87 Participants n=6 Participants	204 Participants n=64 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	2 Participants n=6 Participants	1 Participants n=6 Participants	3 Participants n=64 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	1 Participants n=6 Participants	5 Participants n=6 Participants	7 Participants n=64 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	7 Participants n=6 Participants	7 Participants n=6 Participants	17 Participants n=64 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants	5 Participants n=21 Participants	3 Participants n=10 Participants	10 Participants n=115 Participants	80 Participants n=6 Participants	76 Participants n=6 Participants	191 Participants n=64 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	1 Participants n=6 Participants	2 Participants n=64 Participants

PRIMARY outcome

Timeframe: Up to 1 year in absence of unacceptable toxicity or disease progression.

Population: The DLT Evaluable Population comprised all participants who received at least 1 partial dose of tarextumab during the Phase 1b dose escalation portion of the study (enrolled before the MTD was determined) and who completed Day 15 of Cycle 1 tarextumab administration or discontinued due to drug-related toxicity.

Outcome measures

Outcome measures
Measure	P1B: OMP-59R5 2.5 mg/kg + Gem n=4 Participants Cohort 1: Subjects receive OMP-59R5 2.5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	P1B: OMP-59R5 5 mg/kg + Gem n=4 Participants Cohort 2: Subjects receive OMP-59R5 5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	P1B: OMP-59R5 5 mg/kg + Nab-P + Gem n=4 Participants Cohort 3: Subjects receive OMP-59R5 5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	P1B: OMP-59R5 7.5 mg/kg + Nab-P + Gem n=6 Participants Cohort 4: Subjects receive OMP-59R5 7.5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	P1B: OMP-59R5 10 mg/kg + Nab-P + Gem n=6 Participants Cohort 5: Subjects receive OMP-59R5 10 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	P1B: OMP-59R5 12.5 mg/kg + Nab-P + Gem n=3 Participants Cohort 6: Subjects receive OMP-59R5 12.5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	P1B: OMP-59R5 15 mg/kg + Nab-P + Gem n=10 Participants Expansion Cohort: Subjects receive OMP-59R5 15 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).
Phase Ib: Number of Participants With Dose-limiting Toxicities (DLT)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Up to 1 year in absence of unacceptable toxicity or disease progression.

To determine the clinical benefit, as measured by overall survival (OS) ofthe addition of OMP-59R5 to nab-paclitaxel and gemcitabine in all subjects who are receiving first-line therapy for stage IV pancreatic cancer.

Outcome measures

Outcome measures
Measure	P1B: OMP-59R5 2.5 mg/kg + Gem n=88 Participants Cohort 1: Subjects receive OMP-59R5 2.5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	P1B: OMP-59R5 5 mg/kg + Gem n=89 Participants Cohort 2: Subjects receive OMP-59R5 5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	P1B: OMP-59R5 5 mg/kg + Nab-P + Gem Cohort 3: Subjects receive OMP-59R5 5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	P1B: OMP-59R5 7.5 mg/kg + Nab-P + Gem Cohort 4: Subjects receive OMP-59R5 7.5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	P1B: OMP-59R5 10 mg/kg + Nab-P + Gem Cohort 5: Subjects receive OMP-59R5 10 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	P1B: OMP-59R5 12.5 mg/kg + Nab-P + Gem Cohort 6: Subjects receive OMP-59R5 12.5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	P1B: OMP-59R5 15 mg/kg + Nab-P + Gem Expansion Cohort: Subjects receive OMP-59R5 15 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).
Phase 2: Overall Survival (ITT Population) Number of subjects who died	60 participants	71 participants	—	—	—	—	—
Phase 2: Overall Survival (ITT Population) Number of subjects who did not die	28 participants	18 participants	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to 1 year in absence of unacceptable toxicity or disease progression.

Population: The Intent-to-Treat (ITT) Population comprised all participants who received at least 1 partial dose of tarextumab. Here, Overall Number of Participants Analyzed = number of participants with Notch 3 ≥ 25th percentile, and Number Analyzed = number of participants in each Notch 3 percentile subset.

To determine the clinical benefit, as measured by OS of the addition of OMP-59R5 to Nab-P+Gem across the 4 subject subsets: subjects with Notch3 ≥ 25th percentile, subjects with Notch3 ≥ 50th percentile, subjects with Notch3 ≥ 75th percentile and all subjects receiving first-line therapy for stage IV pancreatic cancer with Notch3 high expression level.

Outcome measures

Outcome measures
Measure	P1B: OMP-59R5 2.5 mg/kg + Gem n=55 Participants Cohort 1: Subjects receive OMP-59R5 2.5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	P1B: OMP-59R5 5 mg/kg + Gem n=55 Participants Cohort 2: Subjects receive OMP-59R5 5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	P1B: OMP-59R5 5 mg/kg + Nab-P + Gem Cohort 3: Subjects receive OMP-59R5 5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	P1B: OMP-59R5 7.5 mg/kg + Nab-P + Gem Cohort 4: Subjects receive OMP-59R5 7.5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	P1B: OMP-59R5 10 mg/kg + Nab-P + Gem Cohort 5: Subjects receive OMP-59R5 10 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	P1B: OMP-59R5 12.5 mg/kg + Nab-P + Gem Cohort 6: Subjects receive OMP-59R5 12.5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	P1B: OMP-59R5 15 mg/kg + Nab-P + Gem Expansion Cohort: Subjects receive OMP-59R5 15 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).
Phase 2: Median OS by Notch 3 Percentile (ITT Population) Notch 3 ≥ 75th percentile	187.5 Days Interval 95.0 to Upper 95% CI was not reached	228.0 Days Interval 101.0 to 453.0	—	—	—	—	—
Phase 2: Median OS by Notch 3 Percentile (ITT Population) Notch 3 ≥ 50th percentile	220.5 Days Interval 135.0 to 329.0	151.0 Days Interval 101.0 to 258.0	—	—	—	—	—
Phase 2: Median OS by Notch 3 Percentile (ITT Population) Notch 3 ≥ 25th percentile	206.0 Days Interval 146.0 to 312.0	165.0 Days Interval 123.0 to 252.0	—	—	—	—	—

Adverse Events

P1B: OMP-59R5 2.5 mg/kg + Gem

Serious events: 4 serious events

Other events: 5 other events

Deaths: 3 deaths

P1B: OMP-59R5 5 mg/kg + Gem

Serious events: 1 serious events

Other events: 4 other events

Deaths: 4 deaths

P1B: OMP-59R5 5 mg/kg + Nab-P + Gem

Serious events: 1 serious events

Other events: 4 other events

Deaths: 4 deaths

P1B: OMP-59R5 7.5 mg/kg + Nab-P + Gem

Serious events: 3 serious events

Other events: 6 other events

Deaths: 5 deaths

P1B: OMP-59R5 10 mg/kg + Nab-P + Gem

Serious events: 4 serious events

Other events: 6 other events

Deaths: 6 deaths

P1B: OMP-59R5 12.5 mg/kg + Nab-P + Gem

Serious events: 1 serious events

Other events: 3 other events

Deaths: 3 deaths

P1B: OMP-59R5 15 mg/kg + Nab-P + Gem

Serious events: 9 serious events

Other events: 12 other events

Deaths: 10 deaths

P2: Placebo + Nab-P + Gem

Serious events: 51 serious events

Other events: 85 other events

Deaths: 60 deaths

P2: OMP-59R5 15 mg/kg + Nab-P + Gem

Serious events: 58 serious events

Other events: 87 other events

Deaths: 71 deaths

Serious adverse events

Serious adverse events
Measure	P1B: OMP-59R5 2.5 mg/kg + Gem n=5 participants at risk Cohort 1: Subjects receive OMP-59R5 2.5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	P1B: OMP-59R5 5 mg/kg + Gem n=4 participants at risk Cohort 2: Subjects receive OMP-59R5 5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	P1B: OMP-59R5 5 mg/kg + Nab-P + Gem n=4 participants at risk Cohort 3: Subjects receive OMP-59R5 5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	P1B: OMP-59R5 7.5 mg/kg + Nab-P + Gem n=6 participants at risk Cohort 4: Subjects receive OMP-59R5 7.5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	P1B: OMP-59R5 10 mg/kg + Nab-P + Gem n=6 participants at risk Cohort 5: Subjects receive OMP-59R5 10 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	P1B: OMP-59R5 12.5 mg/kg + Nab-P + Gem n=3 participants at risk Cohort 6: Subjects receive OMP-59R5 12.5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	P1B: OMP-59R5 15 mg/kg + Nab-P + Gem n=12 participants at risk Expansion Cohort: Subjects receive OMP-59R5 15 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	P2: Placebo + Nab-P + Gem n=85 participants at risk Placebo Arm: Subjects receive placebo (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	P2: OMP-59R5 15 mg/kg + Nab-P + Gem n=87 participants at risk Active Arm: Subjects receive OMP-59R5 15 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).
Gastrointestinal disorders Gastrointestinal haemorrhage	20.0% 1/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 1/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 3/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	4.7% 4/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	6.9% 6/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Constipation	20.0% 1/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.3% 2/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Diarrhoea	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 2/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.4% 2/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.0% 7/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Duodenal obstruction	20.0% 1/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Duodenal ulcer	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Faecaloma	20.0% 1/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Nausea	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	33.3% 1/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	4.6% 4/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	4.7% 4/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.3% 2/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	20.0% 1/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.4% 2/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Vomiting	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	33.3% 1/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	3.5% 3/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	5.7% 5/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Pneumonia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	4.7% 4/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	3.4% 3/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Cellulitis	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	7.1% 6/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Biliary tract infection	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Escherichia bacteraemia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	3.5% 3/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Enterobacter bacteraemia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Escherichia sepsis	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Cholecystitis infective	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Urinary tract infection	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.3% 2/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Atypical pneumonia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Bacteraemia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Clostridium difficile colitis	20.0% 1/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.3% 2/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Clostridium difficile infection	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.3% 2/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Gastroenteritis	20.0% 1/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Groin Abscess	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Herpes zoster	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Gastroenteritis viral	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Infection	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Klebsiella bacteraemia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Lobar pneumonia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Peritonitis	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Peritonitis bacterial	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Staphylococcal bacteraemia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Staphylococcal sepsis	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Sepsis	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	7.1% 6/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	4.6% 4/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Staphylococcal skin infection	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	33.3% 1/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Subcutaneous abscess	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	33.3% 1/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
General disorders Fatigue	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
General disorders Death	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
General disorders Pyrexia	20.0% 1/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	10.6% 9/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	5.7% 5/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	33.3% 2/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	3.5% 3/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	5.7% 5/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Respiratory, thoracic and mediastinal disorders Pulmonary infarction	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Blood and lymphatic system disorders Anaemia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 2/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.4% 2/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	4.6% 4/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	6.9% 6/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Nervous system disorders Metabolic encephalopathy	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 1/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Nervous system disorders Presyncope	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Nervous system disorders Thrombotic stroke	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Hepatobiliary disorders Cholangitis	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.4% 2/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	3.4% 3/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.3% 2/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.3% 2/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Cardiac disorders Atrial fibrillation	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	3.5% 3/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Investigations Blood bilirubin increased	20.0% 1/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 1/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	4.7% 4/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	9.2% 8/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Vascular disorders Venous thrombosis limb	20.0% 1/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Small intestinal perforation	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 1/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Abdominal pain	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	3.5% 3/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Obstruction gastric	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.3% 2/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Ileus	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.3% 2/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Ascites	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Haematochezia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Impaired gastric emptying	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Intestinal perforation	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Large intestine perforation	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
General disorders Asthenia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.4% 2/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
General disorders Catheter site haemorrhage	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
General disorders Catheter site pain	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
General disorders Oedema	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
General disorders Oedema peripheral	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
General disorders Pain	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
General disorders Systemic inflammatory response syndrome	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.4% 2/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.3% 2/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.4% 2/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Respiratory, thoracic and mediastinal disorders Pulmonary toxicity	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	3.5% 3/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Blood and lymphatic system disorders Neutropenia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.4% 2/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Blood and lymphatic system disorders Haemolytic uraemic syndrome	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Blood and lymphatic system disorders Leukopenia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Blood and lymphatic system disorders Microangiopathic haemolytic anaemia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Blood and lymphatic system disorders Thrombotic thrombocytopenic purpura	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Metabolism and nutrition disorders Dehydration	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	5.9% 5/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	3.4% 3/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.4% 2/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma metastatic	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Hepatobiliary disorders Bile duct stenosis	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Hepatobiliary disorders Cholangitis acute	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Hepatobiliary disorders Cholecystitis	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Hepatobiliary disorders Hepatic failure	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Cardiac disorders Cardiac arrest	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.4% 2/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Cardiac disorders Cardiac failure congestive	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Cardiac disorders Cardiomyopathy	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Cardiac disorders Myocardial infarction	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Cardiac disorders Sinus bradycardia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Vascular disorders Deep vein thrombosis	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.4% 2/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Vascular disorders Embolism	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Vascular disorders Hypotension	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.3% 2/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Vascular disorders Arterial occlusive disease	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Vascular disorders Haematoma	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Vascular disorders Hypertension	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Renal and urinary disorders Renal failure acute	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	4.7% 4/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	3.4% 3/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Renal and urinary disorders Nephrolithiasis	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Nervous system disorders Cerebrovascular accident	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Nervous system disorders Cerebral infarction	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Nervous system disorders Encephalopathy	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Nervous system disorders Ischaemic stroke	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Investigations Alanine aminotransferase increased	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Investigations Lipase increased	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Immune system disorders Hypersensitivity	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.

Other adverse events

Other adverse events
Measure	P1B: OMP-59R5 2.5 mg/kg + Gem n=5 participants at risk Cohort 1: Subjects receive OMP-59R5 2.5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	P1B: OMP-59R5 5 mg/kg + Gem n=4 participants at risk Cohort 2: Subjects receive OMP-59R5 5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	P1B: OMP-59R5 5 mg/kg + Nab-P + Gem n=4 participants at risk Cohort 3: Subjects receive OMP-59R5 5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	P1B: OMP-59R5 7.5 mg/kg + Nab-P + Gem n=6 participants at risk Cohort 4: Subjects receive OMP-59R5 7.5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	P1B: OMP-59R5 10 mg/kg + Nab-P + Gem n=6 participants at risk Cohort 5: Subjects receive OMP-59R5 10 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	P1B: OMP-59R5 12.5 mg/kg + Nab-P + Gem n=3 participants at risk Cohort 6: Subjects receive OMP-59R5 12.5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	P1B: OMP-59R5 15 mg/kg + Nab-P + Gem n=12 participants at risk Expansion Cohort: Subjects receive OMP-59R5 15 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	P2: Placebo + Nab-P + Gem n=85 participants at risk Placebo Arm: Subjects receive placebo (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	P2: OMP-59R5 15 mg/kg + Nab-P + Gem n=87 participants at risk Active Arm: Subjects receive OMP-59R5 15 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).
Psychiatric disorders Insomnia	20.0% 1/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	10.6% 9/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	12.6% 11/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Blood and lymphatic system disorders Thrombocytopenia	60.0% 3/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	50.0% 2/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	100.0% 4/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	83.3% 5/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	83.3% 5/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	66.7% 2/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	58.3% 7/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	44.7% 38/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	71.3% 62/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Blood and lymphatic system disorders Anemia	80.0% 4/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	50.0% 2/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	50.0% 2/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	50.0% 3/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	83.3% 5/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	66.7% 2/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	75.0% 9/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	54.1% 46/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	57.5% 50/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Blood and lymphatic system disorders Neutropenia	40.0% 2/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 1/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	50.0% 3/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 2/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	49.4% 42/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	24.1% 21/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Blood and lymphatic system disorders Leukopenia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	14.1% 12/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	12.6% 11/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
General disorders Diarrhoea	60.0% 3/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 1/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	100.0% 4/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	66.7% 4/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	66.7% 4/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	33.3% 1/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	83.3% 10/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	48.2% 41/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	81.6% 71/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Nausea	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	50.0% 2/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	33.3% 2/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	50.0% 3/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	33.3% 1/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	75.0% 9/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	55.3% 47/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	63.2% 55/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Vomiting	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	50.0% 2/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	33.3% 2/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	50.0% 3/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	33.3% 1/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	66.7% 8/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	37.6% 32/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	37.9% 33/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Constipation	40.0% 2/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	41.7% 5/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	30.6% 26/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.1% 14/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Abdominal pain	20.0% 1/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 1/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	50.0% 3/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 3/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	24.7% 21/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	18.4% 16/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	5.9% 5/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	5.7% 5/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Dyspepsia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	7.1% 6/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	4.6% 4/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Gastrooesphageal reflux disease	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 1/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	33.3% 2/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 3/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.4% 2/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.3% 2/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Gastrointestinal Haemorrhage	20.0% 1/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 1/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 3/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	4.7% 4/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.0% 7/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Abdominal distension	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 1/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	33.3% 2/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	10.6% 9/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	9.2% 8/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Flatulence	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	33.3% 2/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	91.7% 11/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	3.5% 3/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.3% 2/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	3.5% 3/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.3% 2/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Anorectal discomfort	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Ascites	20.0% 1/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 1/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.2% 7/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Haemorrhoids	20.0% 1/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.4% 2/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.3% 2/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Colitis	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Dental Caries	20.0% 1/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Duodenal obstruction	20.0% 1/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.4% 2/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Duodenal ulcer	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Dysphagia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Eructation	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Faecaloma	20.0% 1/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Gastrointestinal disorder	20.0% 1/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Melaena	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Oesophageal ulcer	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Oral disorder	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Oral pain	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Pancreatic insufficiency	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	33.3% 1/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Rectal fissure	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	4.7% 4/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.3% 2/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Small intestinal perforation	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 1/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Stomatitis	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	4.7% 4/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	5.7% 5/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	20.0% 1/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.4% 2/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
General disorders Fatigue	40.0% 2/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	50.0% 2/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	66.7% 4/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	83.3% 5/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	91.7% 11/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	69.4% 59/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	72.4% 63/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
General disorders Oedema Peripheral	40.0% 2/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	100.0% 4/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	33.3% 2/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 3/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	31.8% 27/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.1% 14/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
General disorders Pyrexia	40.0% 2/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	75.0% 3/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	41.7% 5/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	42.4% 36/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.3% 22/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
General disorders Asthenia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	50.0% 2/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	33.3% 4/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	11.8% 10/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	10.3% 9/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
General disorders Chills	20.0% 1/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 3/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	15.3% 13/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.0% 7/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
General disorders Mucosal inflammation	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 2/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	4.7% 4/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	6.9% 6/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
General disorders Early satiety	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 1/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
General disorders Gait disturbance	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 2/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.4% 2/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.3% 2/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
General disorders Influenza like illness	20.0% 1/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 1/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	3.5% 3/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.3% 2/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
General disorders Catheter site erythema	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
General disorders Catheter site pruritus	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
General disorders Chest Pain	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	3.5% 3/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
General disorders Face oedema	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 1/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
General disorders Instillation site erythema	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
General disorders Localised oedema	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	3.5% 3/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
General disorders Medical device complication	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 1/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
General disorders Pain	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.5% 14/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	19.5% 17/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Metabolism and nutrition disorders Decreased appetite	20.0% 1/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	50.0% 2/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	33.3% 2/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	33.3% 2/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	33.3% 1/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	66.7% 8/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.9% 22/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	31.0% 27/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Metabolism and nutrition disorders Hypokalaemia	20.0% 1/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 1/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 1/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	33.3% 2/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	33.3% 1/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	33.3% 4/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.5% 14/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	26.4% 23/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Metabolism and nutrition disorders Dehydration	20.0% 1/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 1/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	33.3% 2/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	50.0% 6/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	21.2% 18/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	21.8% 19/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Metabolism and nutrition disorders Hypoalbuminaemia	20.0% 1/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 1/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 2/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	12.9% 11/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	9.2% 8/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	33.3% 4/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	10.6% 9/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	12.6% 11/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 1/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 3/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	12.9% 11/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	5.7% 5/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 1/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 2/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	10.6% 9/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.0% 7/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 3/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	10.6% 9/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	6.9% 6/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Metabolism and nutrition disorders Hypercreatininaemia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	33.3% 1/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	3.5% 3/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.4% 2/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	10.6% 9/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	5.7% 5/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	66.7% 4/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	50.0% 3/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	33.3% 1/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	50.0% 6/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	30.6% 26/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.3% 22/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Skin and subcutaneous tissue disorders Pruritus	20.0% 1/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 1/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 3/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.2% 7/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	11.5% 10/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Skin and subcutaneous tissue disorders Erythema	40.0% 2/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 1/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	3.5% 3/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Skin and subcutaneous tissue disorders Rash	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	22.4% 19/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	20.7% 18/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	33.3% 2/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 2/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	6.9% 6/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 2/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Skin and subcutaneous tissue disorders Petechiae	20.0% 1/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Skin and subcutaneous tissue disorders Rash macular	20.0% 1/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	20.0% 1/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.4% 2/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Skin and subcutaneous tissue disorders Skin ulcer	20.0% 1/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Skin and subcutaneous tissue disorders Blister	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.4% 2/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Skin and subcutaneous tissue disorders Dermal cyst	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 1/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.4% 2/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	4.6% 4/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Skin and subcutaneous tissue disorders Ecchymosis	20.0% 1/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Skin and subcutaneous tissue disorders Ingrowing nail	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Skin and subcutaneous tissue disorders Pruritus generalized	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Skin and subcutaneous tissue disorders Rash pruritic	20.0% 1/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Skin and subcutaneous tissue disorders Skin discoloration	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Nervous system disorders Neuropathy Peripheral	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	50.0% 2/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	50.0% 3/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	33.3% 4/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	22.4% 19/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	19.5% 17/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Nervous system disorders Dizziness	20.0% 1/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	50.0% 2/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	33.3% 2/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	21.2% 18/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	12.6% 11/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Nervous system disorders Dysgeusia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	33.3% 4/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	17.6% 15/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	23.0% 20/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	33.3% 2/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 2/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	17.6% 15/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.0% 7/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Nervous system disorders Headache	20.0% 1/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 1/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	10.6% 9/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	9.2% 8/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Nervous system disorders Ageusia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Nervous system disorders Dysaesthesia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Nervous system disorders Hypoaesthesia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 1/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.4% 2/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.3% 2/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Nervous system disorders Metabolic encephalopathy	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 1/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Nervous system disorders Peripheral motor neuropathy	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	3.5% 3/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Nervous system disorders Presyncope	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Nervous system disorders Syncope	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	3.4% 3/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Nervous system disorders Thrombotic stroke	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Nervous system disorders Tremor	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.4% 2/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Vascular disorders Hypotension	20.0% 1/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	50.0% 2/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	33.3% 2/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	33.3% 4/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	7.1% 6/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	11.5% 10/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Vascular disorders Deep vein thrombosis	20.0% 1/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	33.3% 2/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	14.1% 12/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	5.7% 5/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Vascular disorders Hot flush	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Vascular disorders Orthostatic hypotension	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 1/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 1/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Vascular disorders Embolism	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 1/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	4.7% 4/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Vascular disorders Hypertension	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	5.9% 5/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Vascular disorders Venous thrombosis limb	20.0% 1/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Investigations Weight decreased	20.0% 1/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 1/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	50.0% 3/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	33.3% 2/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 3/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	10.6% 9/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	13.8% 12/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Investigations White blood cell count decreased	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 3/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Investigations Blood alkaline phosphatase increased	40.0% 2/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 1/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.5% 14/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	14.9% 13/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Investigations Alanine aminotransferase increased	20.0% 1/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.5% 14/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	13.8% 12/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Investigations Aspartate aminotransferase increased	40.0% 2/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	15.3% 13/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	10.3% 9/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Investigations Blood bilirubin increased	40.0% 2/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	7.1% 6/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	9.2% 8/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Investigations International normalised ratio increased	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	50.0% 2/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	5.9% 5/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	3.4% 3/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Investigations Lymphocyte count decreased	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 2/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	9.4% 8/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	5.7% 5/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 1/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	4.7% 4/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.3% 2/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Investigations Blood creatinine increased	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Investigations Cardiac murmur	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Investigations Prothrombin time prolonged	20.0% 1/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Pneumonia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 3/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	7.1% 6/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	5.7% 5/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Upper respiratory tract infection	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 3/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.2% 7/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.3% 2/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Oral candidiasis	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.4% 2/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Staphylococcal infection	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 1/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	33.3% 1/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Urinary tract infection	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	4.7% 4/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	11.5% 10/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Bacteraemia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Bronchitis	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Candidiasis	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Cellulitis	20.0% 1/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	12.9% 11/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	3.4% 3/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Clostridium difficile colitis	20.0% 1/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.3% 2/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Folliculitis	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	3.4% 3/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Gastroenteritis	20.0% 1/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Gastroenteritis viral	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Hordeolum	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.4% 2/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Infected dermal cyst	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Infection	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.4% 2/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Liver abscess	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Mucosal infection	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Rhinitis	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 1/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.4% 2/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Sepsis	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	7.1% 6/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	4.6% 4/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Sinusitis	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	33.3% 1/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Soft tissue infection	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Staphylococcal skin infection	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	33.3% 1/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Subcutaneous abscess	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	33.3% 1/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 1/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	33.3% 2/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 3/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	9.4% 8/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	20.7% 18/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Respiratory, thoracic and mediastinal disorders Dyspnoea	20.0% 1/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 1/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 2/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.9% 22/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	18.4% 16/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 1/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	12.9% 11/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	14.9% 13/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	33.3% 2/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	9.4% 8/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.0% 7/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 1/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 1/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	3.5% 3/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.4% 2/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.3% 2/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 1/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	5.9% 5/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	4.6% 4/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 1/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	20.0% 1/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Respiratory, thoracic and mediastinal disorders Hypoxia	20.0% 1/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.3% 2/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Respiratory, thoracic and mediastinal disorders Painful respiration	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Respiratory, thoracic and mediastinal disorders Pulmonary infarction	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Respiratory, thoracic and mediastinal disorders Respiratory failure	20.0% 1/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.4% 2/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.3% 2/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 1/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	20.0% 1/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 1/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.3% 2/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 1/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	33.3% 1/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 2/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	4.7% 4/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	4.6% 4/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 3/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	15.3% 13/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	9.2% 8/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 1/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	33.3% 2/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	11.8% 10/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	9.2% 8/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 2/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	4.7% 4/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 2/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	9.4% 8/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	3.4% 3/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Musculoskeletal and connective tissue disorders Arthritis	20.0% 1/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Musculoskeletal and connective tissue disorders Exostosis	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.3% 2/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Musculoskeletal and connective tissue disorders Osteopenia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 1/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Musculoskeletal and connective tissue disorders Pubic pain	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Injury, poisoning and procedural complications Fall	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 1/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.3% 2/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 1/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	5.7% 5/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Injury, poisoning and procedural complications Laceration	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	33.3% 1/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Injury, poisoning and procedural complications Contusion	20.0% 1/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Injury, poisoning and procedural complications Limb injury	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Injury, poisoning and procedural complications Subdermal haematoma	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Cardiac disorders Atrial fibrillation	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	4.7% 4/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Psychiatric disorders Depression	20.0% 1/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 1/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	10.6% 9/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	4.6% 4/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Psychiatric disorders Anxiety	20.0% 1/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	7.1% 6/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	6.9% 6/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Psychiatric disorders Confusional state	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 1/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.4% 2/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Cardiac disorders Intracardiac thrombus	20.0% 1/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Cardiac disorders Palpitations	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.4% 2/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Cardiac disorders Sinus tachycardia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Cardiac disorders Tachycardia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	4.7% 4/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	6.9% 6/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Hepatobiliary disorders Cholangitis	20.0% 1/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.4% 2/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	3.4% 3/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.4% 2/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.3% 2/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Hepatobiliary disorders Jaundice	20.0% 1/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Immune system disorders Seasonal allergy	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 2/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Immune system disorders Hypersensitivity	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Renal and urinary disorders Haematuria	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.4% 2/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Renal and urinary disorders Hypertonic bladder	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Renal and urinary disorders Urinary retention	20.0% 1/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.3% 2/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 1/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Reproductive system and breast disorders Priapism	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	16.7% 1/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Reproductive system and breast disorders Scrotal cyst	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Eye disorders Eye pruritus	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	8.3% 1/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	25.0% 1/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Dry mouth	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.4% 2/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	4.6% 4/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Haematochezia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.4% 2/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.3% 2/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Obstruction gastric	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.3% 2/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Ileus	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.3% 2/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Impaired gastric emptying	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Inguinal hernia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.3% 2/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Retching	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.4% 2/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Abdominal rigidity	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Cheilitis	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Abdominal tenderness	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Change of bowel habit	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Diarrhoea haemorrhagic	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Duodenal stenosis	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Epigastric discomfort	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Faeces soft	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Gastric ulcer	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Gastritis	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Haematemesis	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Intestinal perforation	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Large intestine perforation	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Lip swelling	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Oesophagitis	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Pneumoperitoneum	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Sensitivity of teeth	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Tongue discolouration	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Tongue disorder	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Tooth disorder	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
General disorders Oedema	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	14.1% 12/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	6.9% 6/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
General disorders Malaise	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	5.9% 5/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
General disorders Infusion site pain	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	3.4% 3/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
General disorders Chest discomfort	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.3% 2/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
General disorders Infusion site discomfort	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
General disorders Peripheral swelling	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.4% 2/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Gastrointestinal disorders Systemic inflammatory response syndrome	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
General disorders Catheter site haemorrhage	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
General disorders Catheter site pain	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
General disorders Device occlusion	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
General disorders Infusion site irritation	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
General disorders Injection site reaction	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
General disorders Non-cardiac chest pain	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	4.7% 4/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Blood and lymphatic system disorders Coagulopathy	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Blood and lymphatic system disorders Haemolytic uraemic syndrome	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Blood and lymphatic system disorders Hypercoagulation	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Blood and lymphatic system disorders Lymph node pain	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Blood and lymphatic system disorders Microangiopathic haemolytic anaemia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Blood and lymphatic system disorders Normochromic normocytic anaemia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Blood and lymphatic system disorders Splenic infarction	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Blood and lymphatic system disorders Splenic vein thrombosis	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Blood and lymphatic system disorders Thrombocytosis	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	5.9% 5/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	4.7% 4/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.4% 2/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.3% 2/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Metabolism and nutrition disorders Acidosis	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Metabolism and nutrition disorders Fluid retention	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Metabolism and nutrition disorders Iron deficiency	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Nervous system disorders Paraesthesia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	3.5% 3/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	6.9% 6/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Nervous system disorders Cerebrovascular accident	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Nervous system disorders Encephalopathy	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.3% 2/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Nervous system disorders Lethargy	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Nervous system disorders Memory impairment	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.4% 2/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Nervous system disorders Neuralgia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.4% 2/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Nervous system disorders Somnolence	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Nervous system disorders Amnesia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Nervous system disorders Balance disorder	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Nervous system disorders Sedation	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Nervous system disorders Burning sensation	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Nervous system disorders Cerebral infarction	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Nervous system disorders Hemianopia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Nervous system disorders Hyporeflexia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Nervous system disorders Ischaemic stroke	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Nervous system disorders Migraine	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Nervous system disorders Motor dysfunction	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Nervous system disorders Nystagmus	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Nervous system disorders Peroneal nerve palsy	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Nervous system disorders Restless legs syndrome	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Nervous system disorders Sciatica	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	4.7% 4/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	6.9% 6/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	5.9% 5/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.3% 2/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	4.7% 4/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	3.5% 3/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.3% 2/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	3.5% 3/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Respiratory, thoracic and mediastinal disorders Nasal discomfort	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.4% 2/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Respiratory, thoracic and mediastinal disorders Nasal dryness	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Respiratory, thoracic and mediastinal disorders Nasal ulcer	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Respiratory, thoracic and mediastinal disorders Pulmonary toxicity	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Respiratory, thoracic and mediastinal disorders Rales	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Respiratory, thoracic and mediastinal disorders Sinus disorder	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	3.5% 3/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.3% 2/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	5.9% 5/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Skin and subcutaneous tissue disorders Nail discolouration	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	3.5% 3/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Skin and subcutaneous tissue disorders Nail disorder	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.4% 2/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.3% 2/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Skin and subcutaneous tissue disorders Acne	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Skin and subcutaneous tissue disorders Nail pigmentation	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Skin and subcutaneous tissue disorders Nail ridging	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Skin and subcutaneous tissue disorders Onychoclasis	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Skin and subcutaneous tissue disorders Onychomadesis	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Skin and subcutaneous tissue disorders Photosensitivity reaction	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Skin and subcutaneous tissue disorders Pruritus generalised	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Skin and subcutaneous tissue disorders Skin disorder	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Skin and subcutaneous tissue disorders Skin mass	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Escherichia bacteraemia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	3.5% 3/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Clostridium difficile infection	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	3.4% 3/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Cystitis	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	3.5% 3/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Fungal skin infection	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	3.5% 3/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Nasopharyngitis	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.4% 2/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Candida infection	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Device related infection	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Furuncle	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Herpes zoster	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Pharyngitis	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.4% 2/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Atypical pneumonia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Biliary tract infection	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Catheter site infection	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Cholecystitis infective	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Diverticulitis	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Enterobacter bacteraemia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Escherichia sepsis	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Groin abscess	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Klebsiella bacteraemia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Lobar pneumonia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Localised infection	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Oral herpes	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Oral infection	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Otitis externa	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Paronychia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Parotitis	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Peritonitis	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Peritonitis bacterial	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Pneumonia klebsiella	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Rash pustular	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Skin infection	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Staphylococcal bacteraemia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Staphylococcal sepsis	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Tooth infection	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Infections and infestations Wound infection	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Investigations Blood glucose increased	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.4% 2/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Investigations Electrocardiogram QT prolonged	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Investigations Bilirubin conjugated increased	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Investigations Blood albumin decreased	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Investigations Blood creatinine decreased	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Investigations Blood fibrinogen decreased	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Investigations Blood parathyroid hormone decreased	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Investigations Blood phosphorus increased	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Investigations Computerised tomogram thorax abnormal	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Investigations Eosinophil count decreased	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Investigations Haematocrit decreased	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Investigations Lipase increased	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Investigations Liver function test abnormal	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Investigations Lymphocyte count increased	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Investigations Neutrophil count increased	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Investigations White blood cell count increased	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Musculoskeletal and connective tissue disorders Hypercreatinaemia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	4.7% 4/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	4.6% 4/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Musculoskeletal and connective tissue disorders Limb discomfort	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.3% 2/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.3% 2/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Vascular disorders Flushing	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.3% 2/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Vascular disorders Haematoma	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.3% 2/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Vascular disorders Phlebitis	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.4% 2/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Vascular disorders Thrombosis	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Vascular disorders Arterial occlusive disease	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Vascular disorders Arteriosclerosis	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Vascular disorders Embolism venous	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Vascular disorders Lymphoedema	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Vascular disorders Orthostatic hypertension	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Vascular disorders Peripheral coldness	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Vascular disorders Shock haemorrhagic	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Vascular disorders Thrombophlebitis superficial	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Psychiatric disorders Restlessness	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.4% 2/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Psychiatric disorders Agitation	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Psychiatric disorders Irritability	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Psychiatric disorders Mental status changes	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Psychiatric disorders Somnambulism	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Renal and urinary disorders Renal failure acute	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	7.1% 6/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	3.4% 3/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Renal and urinary disorders Urinary incontinence	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.4% 2/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.3% 2/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Renal and urinary disorders Dysuria	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	3.4% 3/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Renal and urinary disorders Proteinuria	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.4% 2/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Renal and urinary disorders Cystitis noninfective	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Renal and urinary disorders Glycosuria	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Renal and urinary disorders Hydronephrosis	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Renal and urinary disorders Nephrolithiasis	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Renal and urinary disorders Nocturia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Renal and urinary disorders Oliguria	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Renal and urinary disorders Renal failure	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Renal and urinary disorders Renal failure chronic	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Renal and urinary disorders Urinary tract pain	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Cardiac disorders Cardiac arrest	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.4% 2/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Cardiac disorders Cardiac failure congestive	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.4% 2/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Cardiac disorders Myocardial infarction	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Cardiac disorders Bradycardia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Cardiac disorders Bundle branch block left	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Cardiac disorders Cardiomyopathy	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Cardiac disorders Left ventricular dysfunction	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Cardiac disorders Mitral valve incompetence	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Cardiac disorders Pericardial effusion	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Cardiac disorders Sinus bradycardia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Cardiac disorders Ventricular tachycardia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Hepatobiliary disorders Bile duct obstruction	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	5.9% 5/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	3.4% 3/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Hepatobiliary disorders Portal vein thrombosis	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.4% 2/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Hepatobiliary disorders Bile duct stenosis	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Hepatobiliary disorders Cholangitis acute	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Hepatobiliary disorders Cholangitis sclerosing	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Hepatobiliary disorders Cholecystitis	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Hepatobiliary disorders Gallbladder perforation	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Hepatobiliary disorders Hepatic failure	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Hepatobiliary disorders Hepatic pain	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.3% 2/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Injury, poisoning and procedural complications Skeletal injury	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Skin and subcutaneous tissue disorders Skin abrasion	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Injury, poisoning and procedural complications Sunburn	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Eye disorders Vision blurred	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	5.9% 5/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Eye disorders Dry eye	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.3% 2/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Eye disorders Ocular icterus	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Eye disorders Cataract	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Eye disorders Eye irritation	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Eye disorders Eye pain	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Eye disorders Ocular hyperaemia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Eye disorders Visual impairment	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Eye disorders Xanthopsia	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	4.7% 4/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	9.2% 8/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant ascites	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma metastatic	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Ear and labyrinth disorders Tinnitus	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	2.4% 2/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Ear and labyrinth disorders Ear pain	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Ear and labyrinth disorders Middle ear inflammation	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Ear and labyrinth disorders Vertigo	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Reproductive system and breast disorders Breast pain	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Reproductive system and breast disorders Ovarian vein thrombosis	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Reproductive system and breast disorders Scrotal oedema	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.2% 1/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Reproductive system and breast disorders Vaginal discharge	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/5 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/4 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/6 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/3 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/12 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	0.00% 0/85 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.	1.1% 1/87 • From date of first dose to date of last dose plus 30 days (up to approximately 17 months) An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research. The Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.

Additional Information

Manager, Regulatory Affairs

OncoMed Pharmaceuticals, Inc.

Phone: 6509958322

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place