Trial Outcomes & Findings for Siplizumab in T1DM (NCT NCT05574335)

Last Updated: 2026-07-28

Results Overview

A participant is defined as achieving a T Cell phenotype signature response if the participant experiences both a 75% increase or greater from baseline in the CD4 Treg/Tem ratio in blood and a 20% increase or greater from baseline in PD1+TIGIT+ frequency within circulating CD4 Tem. The two criteria will be evaluated at weeks 2, 4, 8, and 12. Both criteria do not need to be achieved at the same time point.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

8 participants

Primary outcome timeframe

Week 0 to Week 12

Results posted on

2026-07-28

Participant Flow

Twenty sites in the United States were activated. Seventeen adult participants were screened, and 8 adult participants were randomized across 11 sites. The first participant was screened in May 2023, and the last participant was screened in January 2024. Seven participants initiated treatment. Only adult participants were screened and randomized due to the study terminating early.

Participants who met eligibility criteria were randomized without regard to sex, race, or ethnicity. Eligible participants were randomly assigned to one of four doses of siplizumab (0.08 mg/kg/dose, 0.12 mg/kg/dose, 0.18 mg/kg/dose, 0.22 mg/kg/dose). One randomized participant did not initiate treatment and terminated from the study due to moving away from the study site.

Participant milestones

Participant milestones
Measure	Siplizumab 0.08 mg/kg Participants receive a weekly siplizumab dose of 0.08 mg/kg subcutaneously for a total of 12 weeks (up to 12 doses) beginning at Week 0, with the last dose at Week 11.	Siplizumab 0.12 mg/kg Participants receive a weekly siplizumab dose of 0.12 mg/kg subcutaneously for a total of 12 weeks (up to 12 doses) beginning at Week 0, with the last dose at Week 11.	Siplizumab 0.18 mg/kg Participants receive a weekly siplizumab dose of 0.18 mg/kg subcutaneously for a total of 12 weeks (up to 12 doses) beginning at Week 0, with the last dose at Week 11.	Siplizumab 0.22 mg/kg Participants receive a weekly siplizumab dose of 0.22 mg/kg subcutaneously for a total of 12 weeks (up to 12 doses) beginning at Week 0, with the last dose at Week 11.
Overall Study STARTED	3	2	2	1
Overall Study Received 2 Consecutive Doses of Siplizumab	2	2	1	1
Overall Study COMPLETED	2	2	2	1
Overall Study NOT COMPLETED	1	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Siplizumab 0.08 mg/kg Participants receive a weekly siplizumab dose of 0.08 mg/kg subcutaneously for a total of 12 weeks (up to 12 doses) beginning at Week 0, with the last dose at Week 11.	Siplizumab 0.12 mg/kg Participants receive a weekly siplizumab dose of 0.12 mg/kg subcutaneously for a total of 12 weeks (up to 12 doses) beginning at Week 0, with the last dose at Week 11.	Siplizumab 0.18 mg/kg Participants receive a weekly siplizumab dose of 0.18 mg/kg subcutaneously for a total of 12 weeks (up to 12 doses) beginning at Week 0, with the last dose at Week 11.	Siplizumab 0.22 mg/kg Participants receive a weekly siplizumab dose of 0.22 mg/kg subcutaneously for a total of 12 weeks (up to 12 doses) beginning at Week 0, with the last dose at Week 11.
Overall Study Participant was relocating away from the study site	1	0	0	0

Baseline Characteristics

Siplizumab in T1DM

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Siplizumab 0.08 mg/kg n=2 Participants Participants receive a weekly siplizumab dose of 0.08 mg/kg subcutaneously for a total of 12 weeks (up to 12 doses) beginning at Week 0, with the last dose at Week 11.	Siplizumab 0.12 mg/kg n=2 Participants Participants receive a weekly siplizumab dose of 0.12 mg/kg subcutaneously for a total of 12 weeks (up to 12 doses) beginning at Week 0, with the last dose at Week 11.	Siplizumab 0.18 mg/kg n=2 Participants Participants receive a weekly siplizumab dose of 0.18 mg/kg subcutaneously for a total of 12 weeks (up to 12 doses) beginning at Week 0, with the last dose at Week 11.	Siplizumab 0.22 mg/kg n=1 Participants Participants receive a weekly siplizumab dose of 0.22 mg/kg subcutaneously for a total of 12 weeks (up to 12 doses) beginning at Week 0, with the last dose at Week 11.	Total n=7 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=5 Participants	0 Participants n=9 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=20 Participants	2 Participants n=20 Participants	2 Participants n=40 Participants	1 Participants n=5 Participants	7 Participants n=9 Participants
Age, Categorical >=65 years	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=5 Participants	0 Participants n=9 Participants
Age, Continuous	26.5 years n=20 Participants	27.0 years n=20 Participants	32.5 years n=40 Participants	23 years n=5 Participants	23.0 years n=9 Participants
Sex: Female, Male Female	1 Participants n=20 Participants	1 Participants n=20 Participants	0 Participants n=40 Participants	1 Participants n=5 Participants	3 Participants n=9 Participants
Sex: Female, Male Male	1 Participants n=20 Participants	1 Participants n=20 Participants	2 Participants n=40 Participants	0 Participants n=5 Participants	4 Participants n=9 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=5 Participants	0 Participants n=9 Participants
Race (NIH/OMB) Asian	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=5 Participants	0 Participants n=9 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=5 Participants	0 Participants n=9 Participants
Race (NIH/OMB) Black or African American	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=5 Participants	0 Participants n=9 Participants
Race (NIH/OMB) White	2 Participants n=20 Participants	1 Participants n=20 Participants	2 Participants n=40 Participants	1 Participants n=5 Participants	6 Participants n=9 Participants
Race (NIH/OMB) More than one race	0 Participants n=20 Participants	1 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=5 Participants	1 Participants n=9 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=5 Participants	0 Participants n=9 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=5 Participants	0 Participants n=9 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=20 Participants	2 Participants n=20 Participants	2 Participants n=40 Participants	1 Participants n=5 Participants	7 Participants n=9 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=5 Participants	0 Participants n=9 Participants
Region of Enrollment United States	2 Participants n=20 Participants	2 Participants n=20 Participants	2 Participants n=40 Participants	1 Participants n=5 Participants	7 Participants n=9 Participants
Body Mass Index (BMI)	20.09 kg/m^2 n=20 Participants	28.19 kg/m^2 n=20 Participants	24.28 kg/m^2 n=40 Participants	26.75 kg/m^2 n=5 Participants	24.35 kg/m^2 n=9 Participants
2-hour C-peptide mAUC Result in Response to Standardized MMTT	0.797 nmol*min/L n=20 Participants	0.569 nmol*min/L n=20 Participants	0.455 nmol*min/L n=40 Participants	0.990 nmol*min/L n=5 Participants	0.574 nmol*min/L n=9 Participants
Average Insulin Use Per Kilogram Body Weight	0.168 Units per Kilogram Body Weight per Day n=20 Participants	0.582 Units per Kilogram Body Weight per Day n=20 Participants	0.488 Units per Kilogram Body Weight per Day n=40 Participants	0.304 Units per Kilogram Body Weight per Day n=5 Participants	0.342 Units per Kilogram Body Weight per Day n=9 Participants
Days from Type 1 Diabetes Mellitus (T1DM) Diagnosis to Randomization	242.5 Days n=20 Participants	237.0 Days n=20 Participants	440.5 Days n=40 Participants	346.0 Days n=5 Participants	280.0 Days n=9 Participants
Absolute Lymphocyte Count	1.735 X10^3 cells/L n=20 Participants	1.915 X10^3 cells/L n=20 Participants	2.105 X10^3 cells/L n=40 Participants	1.310 X10^3 cells/L n=5 Participants	1.960 X10^3 cells/L n=9 Participants
CD4 Count	738.0 cells/mcL n=20 Participants	781.0 cells/mcL n=20 Participants	1013.0 cells/mcL n=40 Participants	759.0 cells/mcL n=5 Participants	833.0 cells/mcL n=9 Participants

PRIMARY outcome

Timeframe: Week 0 to Week 12

Population: Per protocol (PP) sample: All randomized participants who have viable PBMC samples available following two consecutive doses of siplizumab.

Outcome measures

Outcome measures
Measure	Siplizumab 0.08 mg/kg n=2 Participants Participants receive a weekly siplizumab dose of 0.08 mg/kg subcutaneously for a total of 12 weeks (up to 12 doses) beginning at Week 0, with the last dose at Week 11.	Siplizumab 0.12 mg/kg n=2 Participants Participants receive a weekly siplizumab dose of 0.12 mg/kg subcutaneously for a total of 12 weeks (up to 12 doses) beginning at Week 0, with the last dose at Week 11.	Siplizumab 0.18 mg/kg n=1 Participants Participants receive a weekly siplizumab dose of 0.18 mg/kg subcutaneously for a total of 12 weeks (up to 12 doses) beginning at Week 0, with the last dose at Week 11.	Siplizumab 0.22 mg/kg n=1 Participants Participants receive a weekly siplizumab dose of 0.22 mg/kg subcutaneously for a total of 12 weeks (up to 12 doses) beginning at Week 0, with the last dose at Week 11.
Number of Participants With a T Cell Phenotype Signature Response Criteria 1: ≥75% increase in CD4 Treg/Tem ratio	1 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With a T Cell Phenotype Signature Response Criteria 2: ≥20% increase in PD1+TIGIT+ frequency	2 Participants	2 Participants	1 Participants	1 Participants
Number of Participants With a T Cell Phenotype Signature Response T Cell Phenotype Signature Responder	1 Participants	1 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: From week 0 to week 52

AE will include any untoward medical occurrence associated with siplizumab administration or any study-mandated procedure

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At Week 12, 24, 36, 52

The mean 2-hour C-peptide AUC, measured in nmol/L, is computed by dividing the total AUC by 120 minutes

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At Weeks 12, 24, 36 and 52.

Measured as U/kg body weight/day; participants should record the type and amount of insulin they have used during the 5-day period immediately preceding the beginning of treatment, middle of treatment, end of treatment, and at all follow-up visits

Outcome measures

Outcome data not reported

Adverse Events

Siplizumab 0.08 mg/kg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Siplizumab 0.12 mg/kg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Siplizumab 0.18 mg/kg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Siplizumab 0.22 mg/kg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Director, Clinical Research Operations Program

DAIT/NIAID

Phone: 301-594-7669

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Other adverse events
Measure	Siplizumab 0.08 mg/kg n=2 participants at risk Participants receive a weekly siplizumab dose of 0.08 mg/kg subcutaneously for a total of 12 weeks (up to 12 doses) beginning at Week 0, with the last dose at Week 11.	Siplizumab 0.12 mg/kg n=2 participants at risk Participants receive a weekly siplizumab dose of 0.12 mg/kg subcutaneously for a total of 12 weeks (up to 12 doses) beginning at Week 0, with the last dose at Week 11.	Siplizumab 0.18 mg/kg n=2 participants at risk Participants receive a weekly siplizumab dose of 0.18 mg/kg subcutaneously for a total of 12 weeks (up to 12 doses) beginning at Week 0, with the last dose at Week 11.	Siplizumab 0.22 mg/kg n=1 participants at risk Participants receive a weekly siplizumab dose of 0.22 mg/kg subcutaneously for a total of 12 weeks (up to 12 doses) beginning at Week 0, with the last dose at Week 11.
Cardiac disorders Sinus bradycardia	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.
Cardiac disorders Sinus tachycardia	0.00% 0/2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.
Gastrointestinal disorders Abdominal pain upper	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.
Gastrointestinal disorders Diarrhoea	0.00% 0/2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	100.0% 1/1 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.
Gastrointestinal disorders Nausea	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.
Gastrointestinal disorders Stomatitis	0.00% 0/2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.
Gastrointestinal disorders Vomiting	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.
General disorders and administration site conditions Fatigue	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.
General disorders and administration site conditions Influenza like illness	50.0% 1/2 • Number of events 2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.
General disorders and administration site conditions Injection site reaction	50.0% 1/2 • Number of events 5 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	100.0% 1/1 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.
General disorders and administration site conditions Pain	0.00% 0/2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.
Infections and infestations COVID-19	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.
Infections and infestations Infectious mononucleosis	0.00% 0/2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.
Infections and infestations Pharyngitis	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.
Infections and infestations Urinary tract infection	50.0% 1/2 • Number of events 2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.
Injury, poisoning and procedural complications Sunburn	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.
Investigations CD4 lymphocytes decreased	100.0% 2/2 • Number of events 3 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	100.0% 2/2 • Number of events 2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	100.0% 2/2 • Number of events 2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	100.0% 1/1 • Number of events 2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.
Investigations CD45 expression decreased	0.00% 0/2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.
Investigations Heart rate increased	0.00% 0/2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.
Investigations Lymphocyte count decreased	50.0% 1/2 • Number of events 2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	100.0% 2/2 • Number of events 2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	100.0% 2/2 • Number of events 3 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	100.0% 1/1 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.
Investigations Neutrophil count decreased	50.0% 1/2 • Number of events 5 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.
Investigations Vitamin D decreased	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.
Investigations Weight decreased	0.00% 0/2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	100.0% 1/1 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.
Investigations Weight increased	0.00% 0/2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.
Investigations White blood cell count decreased	50.0% 1/2 • Number of events 4 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	100.0% 2/2 • Number of events 3 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.
Nervous system disorders Headache	0.00% 0/2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	100.0% 1/1 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.
Nervous system disorders Syncope	0.00% 0/2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.
Reproductive system and breast disorders Prostatitis	0.00% 0/2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.
Respiratory, thoracic and mediastinal disorders Nasal congestion	50.0% 1/2 • Number of events 2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.
Skin and subcutaneous tissue disorders Acne	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.
Skin and subcutaneous tissue disorders Skin hypertrophy	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/2 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.	0.00% 0/1 • Treatment-emergent adverse events were recorded in EDC from after treatment initiation at Week 0 until the participant completed study participation or until 30 days after he/she prematurely withdrew (without withdrawing consent) or was withdrawn from the study. All participants were followed until Week 52. Participants who qualified for long-term safety monitoring were followed for an additional 48 weeks, for a total of 100 weeks. All confirmed SARS-CoV-2 infections regardless of grade, symptomatic AEs and ≥Grade 2 asymptomatic AEs, except non-major glycemic events were recorded in EDC. Safety analyses are based on the safety sample, which consists of all participants who receive any amount of siplizumab. Participants will be analyzed according to the actual treatment received.