Trial Outcomes & Findings for Phase II Trial of Efprezimod Alfa (CD24Fc, MK-7110) for the Prevention of Acute Graft-Versus-Host Disease (GVHD) Following Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) (MK-7110-002) (NCT NCT02663622)

Last Updated: 2024-01-23

Results Overview

An AE was defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment. The number of participants who experienced an AE is presented. As described in the protocol, AEs reported after the protocol-specified timeframe were not analyzed in this outcome measure: 1 day prior to hematopoietic stem cell transplantation (HCT) through either 30 or 60 days post-HCT, depending on arm as defined in the Time Frame section.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

44 participants

Primary outcome timeframe

Up to approximately 32 days for the Placebo, CD24Fc 240 mg, and CD24Fc 480 mg arms. Up to approximately 62 days for the CD24Fc 960 mg arm.

Results posted on

2024-01-23

Participant Flow

The CD24Fc 960 mg arm was initiated alongside the other 3 arms. Once the recommended phase 2 dose (RP2D) was determined, the other 3 arms ceased recruitment but additional participants were recruited into the CD24Fc 960 mg arm. Per FDA request, all participants in the CD24Fc 960 mg arm are considered a single population.

Participant milestones

Participant milestones
Measure	Placebo Placebo to CD24Fc (saline IV injection solution) on day -1 or days -1, 14, and 28 + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)	CD24Fc 240 mg CD24Fc in 240 mg as intravenous (IV) infusion at Day -1 + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)	CD24Fc 480 mg CD24Fc in 480 mg as intravenous (IV) infusion at Day -1 + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)	CD24Fc 960 mg CD24Fc (480 mg (day -1), 240 mg (day +14) and 240 mg (day +28)) + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)
Overall Study STARTED	6	6	6	26
Overall Study COMPLETED	3	5	5	17
Overall Study NOT COMPLETED	3	1	1	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo to CD24Fc (saline IV injection solution) on day -1 or days -1, 14, and 28 + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)	CD24Fc 240 mg CD24Fc in 240 mg as intravenous (IV) infusion at Day -1 + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)	CD24Fc 480 mg CD24Fc in 480 mg as intravenous (IV) infusion at Day -1 + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)	CD24Fc 960 mg CD24Fc (480 mg (day -1), 240 mg (day +14) and 240 mg (day +28)) + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)
Overall Study Death	3	1	1	8
Overall Study Protocol Violation	0	0	0	1

Baseline Characteristics

Phase II Trial of Efprezimod Alfa (CD24Fc, MK-7110) for the Prevention of Acute Graft-Versus-Host Disease (GVHD) Following Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) (MK-7110-002)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=6 Participants Placebo to CD24Fc (saline IV injection solution) on day -1 or days -1, 14, and 28 + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)	CD24Fc 240 mg n=6 Participants CD24Fc in 240 mg as intravenous (IV) infusion at Day -1 + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)	CD24Fc 480 mg n=6 Participants CD24Fc in 480 mg as intravenous (IV) infusion at Day -1 + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)	CD24Fc 960 mg n=26 Participants CD24Fc (480 mg (day -1), 240 mg (day +14) and 240 mg (day +28)) + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)	Total n=44 Participants Total of all reporting groups
Age, Customized 18-29 years of age	0 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants	3 Participants n=7 Participants	6 Participants n=31 Participants
Age, Customized 30-39 years of age	1 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	3 Participants n=7 Participants	4 Participants n=31 Participants
Age, Customized 40-49 years of age	1 Participants n=99 Participants	1 Participants n=107 Participants	0 Participants n=206 Participants	4 Participants n=7 Participants	6 Participants n=31 Participants
Age, Customized 50-59 years of age	2 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	8 Participants n=7 Participants	10 Participants n=31 Participants
Age, Customized ≥60 years of age	2 Participants n=99 Participants	4 Participants n=107 Participants	4 Participants n=206 Participants	8 Participants n=7 Participants	18 Participants n=31 Participants
Sex: Female, Male Female	2 Participants n=99 Participants	2 Participants n=107 Participants	2 Participants n=206 Participants	12 Participants n=7 Participants	18 Participants n=31 Participants
Sex: Female, Male Male	4 Participants n=99 Participants	4 Participants n=107 Participants	4 Participants n=206 Participants	14 Participants n=7 Participants	26 Participants n=31 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants	1 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	1 Participants n=31 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=99 Participants	5 Participants n=107 Participants	6 Participants n=206 Participants	26 Participants n=7 Participants	43 Participants n=31 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	1 Participants n=7 Participants	1 Participants n=31 Participants
Race (NIH/OMB) White	6 Participants n=99 Participants	5 Participants n=107 Participants	6 Participants n=206 Participants	25 Participants n=7 Participants	42 Participants n=31 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	1 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	1 Participants n=31 Participants

PRIMARY outcome

Timeframe: Up to approximately 32 days for the Placebo, CD24Fc 240 mg, and CD24Fc 480 mg arms. Up to approximately 62 days for the CD24Fc 960 mg arm.

Population: All participants who enrolled prior to determination of the recommended phase II dose and received at least one dose of study drug.

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants Placebo to CD24Fc (saline IV injection solution) on day -1 or days -1, 14, and 28 + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)	CD24Fc 240 mg n=6 Participants CD24Fc in 240 mg as intravenous (IV) infusion at Day -1 + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)	CD24Fc 480 mg n=6 Participants CD24Fc in 480 mg as intravenous (IV) infusion at Day -1 + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)	CD24Fc 960 mg n=6 Participants CD24Fc (480 mg (day -1), 240 mg (day +14) and 240 mg (day +28)) + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)
Number of Participants Who Experienced an Adverse Event (AE)	6 Participants	6 Participants	6 Participants	6 Participants

PRIMARY outcome

Timeframe: 1 day for the Placebo, CD24Fc 240 mg, and CD24Fc 480 mg arms. Up to approximately 30 days for the CD24Fc 960 mg arm.

Population: All participants who enrolled prior to determination of the recommended phase II dose and received at least one dose of study drug.

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants Placebo to CD24Fc (saline IV injection solution) on day -1 or days -1, 14, and 28 + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)	CD24Fc 240 mg n=6 Participants CD24Fc in 240 mg as intravenous (IV) infusion at Day -1 + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)	CD24Fc 480 mg n=6 Participants CD24Fc in 480 mg as intravenous (IV) infusion at Day -1 + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)	CD24Fc 960 mg n=6 Participants CD24Fc (480 mg (day -1), 240 mg (day +14) and 240 mg (day +28)) + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)
Number of Participants Who Discontinued Study Treatment Due to an AE	1 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 32 days for the Placebo, CD24Fc 240 mg, and CD24Fc 480 mg arms. Up to 62 days for the CD24Fc 960 mg arm.

Population: All participants who enrolled prior to determination of the recommended phase II dose, received at least one dose of study drug, and completed the protocol's DLT evaluation period were analyzed

A DLT was defined as: any Grade III or higher non-hematologic toxicity not clearly related to the underlying malignancy, intercurrent infection, or the hematopoietic stem cell transplantation conditioning regimen; any death not related to relapse or intercurrent infection; and failure to engraft by day 30. Event grading was based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 criteria. Hypersensitivity reactions and other infusion-related reactions were not considered DLTs.

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants Placebo to CD24Fc (saline IV injection solution) on day -1 or days -1, 14, and 28 + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)	CD24Fc 240 mg n=6 Participants CD24Fc in 240 mg as intravenous (IV) infusion at Day -1 + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)	CD24Fc 480 mg n=6 Participants CD24Fc in 480 mg as intravenous (IV) infusion at Day -1 + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)	CD24Fc 960 mg n=6 Participants CD24Fc (480 mg (day -1), 240 mg (day +14) and 240 mg (day +28)) + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)
Number of Participants Who Experienced a Dose-Limiting Toxicity (DLT)	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 181 days

Population: Per protocol, only participants enrolled in the CD24Fc 960 mg arm (from both the dose escalation and expansion phases) who received at least one dose of study drug and underwent HCT were analyzed

AGFS was defined as the time from the date of hematopoietic stem cell transplantation (HCT) to the earliest of Grade III-IV acute GVHD or death due to any cause, whichever occurred first. Event grading was based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 criteria. Participants were censored at 181 days.

Outcome measures

Outcome measures
Measure	Placebo n=26 Participants Placebo to CD24Fc (saline IV injection solution) on day -1 or days -1, 14, and 28 + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)	CD24Fc 240 mg CD24Fc in 240 mg as intravenous (IV) infusion at Day -1 + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)	CD24Fc 480 mg CD24Fc in 480 mg as intravenous (IV) infusion at Day -1 + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)	CD24Fc 960 mg CD24Fc (480 mg (day -1), 240 mg (day +14) and 240 mg (day +28)) + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)
Open Label Expansion Arm Only: Grade III-IV Acute Graft-Versus-Host Disease (GVHD) Free Survival (AGFS)	159.0 Days Standard Deviation 46.86	—	—	—

SECONDARY outcome

Timeframe: Up to 195 days for the Placebo, CD24Fc 240 mg, and CD24Fc 480 mg arms. Up to 181 days for the CD24Fc 960 mg arm.

Population: All participants who received at least one dose of study drug and underwent HCT were analyzed

AGFS was defined as the time from the date of hematopoietic stem cell transplantation (HCT) to the earliest of Grade II-IV acute GVHD or death due to any cause, whichever occurred first. Event grading was based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 criteria. Participants were censored at 195 days for the Placebo, CD24Fc 240 mg, and CD24Fc 480 mg arms, and at 181 days for the CD24Fc 960 mg arm.

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants Placebo to CD24Fc (saline IV injection solution) on day -1 or days -1, 14, and 28 + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)	CD24Fc 240 mg n=6 Participants CD24Fc in 240 mg as intravenous (IV) infusion at Day -1 + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)	CD24Fc 480 mg n=6 Participants CD24Fc in 480 mg as intravenous (IV) infusion at Day -1 + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)	CD24Fc 960 mg n=26 Participants CD24Fc (480 mg (day -1), 240 mg (day +14) and 240 mg (day +28)) + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)
Grade II-IV Acute Graft-Versus-Host Disease (GVHD) Free Survival (AGFS)	144.2 Days Standard Deviation 74.98	145.7 Days Standard Deviation 77.01	116.2 Days Standard Deviation 86.69	125.4 Days Standard Deviation 64.93

SECONDARY outcome

Timeframe: Up to approximately 108 days

Population: All participants who enrolled prior to determination of the recommended phase II dose, received at least one dose of study drug, and underwent HCT were analyzed

The percentage of participants who experienced grade II to IV acute GVHD is presented as cumulative incidence of Grade II to IV acute GVHD by approximately 108 days following HCT. Event grading was based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 criteria. The cumulative incidence (%) of acute GVHD and the 95% CI were estimated using the cumulative incidence function with death without Grade II to IV acute GVHD as a competing risk.

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants Placebo to CD24Fc (saline IV injection solution) on day -1 or days -1, 14, and 28 + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)	CD24Fc 240 mg n=6 Participants CD24Fc in 240 mg as intravenous (IV) infusion at Day -1 + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)	CD24Fc 480 mg n=6 Participants CD24Fc in 480 mg as intravenous (IV) infusion at Day -1 + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)	CD24Fc 960 mg n=6 Participants CD24Fc (480 mg (day -1), 240 mg (day +14) and 240 mg (day +28)) + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)
Percentage of Participants Experiencing Grade II to IV Acute GVHD Following HCT	16.7 Percentage of Participants Interval 0.5 to 54.9	33.3 Percentage of Participants Interval 3.2 to 70.4	50.0 Percentage of Participants Interval 7.7 to 82.9	33.3 Percentage of Participants Interval 3.2 to 70.4

SECONDARY outcome

Timeframe: Up to 380 days

Population: All participants who enrolled prior to determination of the recommended phase II dose, received at least one dose of study drug, and underwent HCT were analyzed.

The percentage of participants who experienced chronic GVHD will be presented as cumulative incidence of chronic GVHD. Chronic GVHD assessments occurred approximately quarterly beginning on Day 100 after HCT until 1 year after HCT. The cumulative incidence (%) of chronic GVHD at 1 year post-HCT and the 95% CI were estimated using the cumulative incidence function with death without chronic GVHD as a competing risk. If the maximum observed time was \<Study Day 380, the cumulative incidence at the maximum observed time is presented for a treatment group.

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants Placebo to CD24Fc (saline IV injection solution) on day -1 or days -1, 14, and 28 + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)	CD24Fc 240 mg n=6 Participants CD24Fc in 240 mg as intravenous (IV) infusion at Day -1 + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)	CD24Fc 480 mg n=6 Participants CD24Fc in 480 mg as intravenous (IV) infusion at Day -1 + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)	CD24Fc 960 mg n=6 Participants CD24Fc (480 mg (day -1), 240 mg (day +14) and 240 mg (day +28)) + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)
Percentage of Participants Experiencing Chronic GVHD Following HCT	33.3 Percentage of Participants Interval 2.5 to 72.0	50.0 Percentage of Participants Interval 7.0 to 83.5	50.0 Percentage of Participants Interval 6.9 to 83.6	83.3 Percentage of Participants Interval 0.5 to 99.4

SECONDARY outcome

Timeframe: Up to 380 days

Population: All participants who enrolled prior to determination of the recommended phase II dose, received at least one dose of study drug, and underwent HCT were analyzed.

The percentage of participants who experienced relapse of disease is presented as cumulative incidence of relapse. The cumulative incidence (%) of relapse at approximately 1 year following HCT and the 95% CI were estimated using the cumulative incidence function with death without relapse as a competing risk. If the maximum observed time is \< Study Day 380, the cumulative incidence at the maximum observed time is presented.

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants Placebo to CD24Fc (saline IV injection solution) on day -1 or days -1, 14, and 28 + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)	CD24Fc 240 mg n=6 Participants CD24Fc in 240 mg as intravenous (IV) infusion at Day -1 + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)	CD24Fc 480 mg n=6 Participants CD24Fc in 480 mg as intravenous (IV) infusion at Day -1 + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)	CD24Fc 960 mg n=6 Participants CD24Fc (480 mg (day -1), 240 mg (day +14) and 240 mg (day +28)) + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)
Percentage of Participants Experiencing Relapse Following HCT	33.3 Percentage of Participants Interval 2.9 to 71.1	0.0 Percentage of Participants The upper and lower limits are not estimable because the 95% CI is obtained using the log-log transformation. Since the estimate is 0, the CI is not estimable.	16.7 Percentage of Participants Interval 0.5 to 54.9	16.7 Percentage of Participants Interval 0.5 to 54.9

SECONDARY outcome

Timeframe: Up to 380 days

Population: All participants who enrolled prior to determination of the recommended phase II dose, received at least one dose of study drug, and underwent HCT were analyzed.

The percentage of participants who experienced NRM is presented as cumulative incidence of NRM. The cumulative incidence (%) of NRM at approximately 1 year following HCT and the 95% CI were estimated using the cumulative incidence function with relapse as a competing risk. If the maximum observed time is \< Study Day 380, the cumulative incidence at the maximum observed time will be presented.

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants Placebo to CD24Fc (saline IV injection solution) on day -1 or days -1, 14, and 28 + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)	CD24Fc 240 mg n=6 Participants CD24Fc in 240 mg as intravenous (IV) infusion at Day -1 + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)	CD24Fc 480 mg n=6 Participants CD24Fc in 480 mg as intravenous (IV) infusion at Day -1 + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)	CD24Fc 960 mg n=6 Participants CD24Fc (480 mg (day -1), 240 mg (day +14) and 240 mg (day +28)) + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)
Percentage of Participants Experiencing Non-Relapse Mortality (NRM) Following HCT	16.7 Percentage of Participants Interval 0.5 to 54.9	16.7 Percentage of Participants Interval 0.5 to 54.9	0.0 Percentage of Participants The upper and lower limits are not estimable because the 95% CI is obtained using the log-log transformation. Since the estimate is 0, the CI is not estimable.	0.0 Percentage of Participants The upper and lower limits are not estimable because the 95% CI is obtained using the log-log transformation. Since the estimate is 0, the CI is not estimable.

SECONDARY outcome

Timeframe: Up to approximately 101 days

Population: All participants who enrolled prior to determination of the recommended phase II dose, received at least one dose of study drug, and underwent HCT were analyzed.

The percentage of participants who experienced infection by approximately 101 days following HCT is presented.

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants Placebo to CD24Fc (saline IV injection solution) on day -1 or days -1, 14, and 28 + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)	CD24Fc 240 mg n=6 Participants CD24Fc in 240 mg as intravenous (IV) infusion at Day -1 + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)	CD24Fc 480 mg n=6 Participants CD24Fc in 480 mg as intravenous (IV) infusion at Day -1 + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)	CD24Fc 960 mg n=6 Participants CD24Fc (480 mg (day -1), 240 mg (day +14) and 240 mg (day +28)) + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)
Percentage of Participants Experiencing Infection Following Hematopoietic Stem Cell Transplantation (HCT)	33.3 Percentage of Participants	83.3 Percentage of Participants	33.3 Percentage of Participants	100.0 Percentage of Participants

SECONDARY outcome

Timeframe: Up to 380 days for the Placebo, CD24Fc 240 mg, and CD24Fc 480 mg arms. Up to 366 days for the CD24Fc 960 mg arm.

Population: All participants who received at least one dose of study drug and underwent HCT were analyzed

OS is defined as the time from HCT to death due to any cause. Participants were censored at 380 days for the Placebo, CD24Fc 240 mg, and CD24Fc 480 mg arms, and at 366 days for the CD24Fc 960 mg arm.

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants Placebo to CD24Fc (saline IV injection solution) on day -1 or days -1, 14, and 28 + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)	CD24Fc 240 mg n=6 Participants CD24Fc in 240 mg as intravenous (IV) infusion at Day -1 + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)	CD24Fc 480 mg n=6 Participants CD24Fc in 480 mg as intravenous (IV) infusion at Day -1 + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)	CD24Fc 960 mg n=26 Participants CD24Fc (480 mg (day -1), 240 mg (day +14) and 240 mg (day +28)) + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)
Overall Survival (OS) Following Hematopoietic Stem Cell Transplantation (HCT)	276.3 Days Standard Deviation 132.25	343.0 Days Standard Deviation 64.34	343.5 Days Standard Deviation 72.45	321.2 Days Standard Deviation 97.62

SECONDARY outcome

Timeframe: Up to 380 days

Population: All participants who enrolled prior to determination of the recommended phase II dose, received at least one dose of study drug, and underwent HCT were analyzed

This GRFS following HCT is a composite endpoint in which events included Grade III to IV acute GVHD, chronic GVHD requiring systemic immunosuppressive therapy, relapse, or death from any cause

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants Placebo to CD24Fc (saline IV injection solution) on day -1 or days -1, 14, and 28 + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)	CD24Fc 240 mg n=6 Participants CD24Fc in 240 mg as intravenous (IV) infusion at Day -1 + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)	CD24Fc 480 mg n=6 Participants CD24Fc in 480 mg as intravenous (IV) infusion at Day -1 + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)	CD24Fc 960 mg n=6 Participants CD24Fc (480 mg (day -1), 240 mg (day +14) and 240 mg (day +28)) + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)
GVHD-Free and Relapse-Free Survival (GRFS) Following HCT	178.7 Days Standard Deviation 151.48	260.5 Days Standard Deviation 99.54	250.3 Days Standard Deviation 149.68	227.2 Days Standard Deviation 123.63

SECONDARY outcome

Timeframe: Up to 380 days for the Placebo, CD24Fc 240 mg, and CD24Fc 480 mg arms. Up to 366 days for the CD24Fc 960 mg arm

Population: All participants who received at least one dose of study drug and underwent HCT were analyzed

RFS is defined as the time from HCT to relapse or death due to any cause. Participants were censored at 380 days for the Placebo, CD24Fc 240 mg, and CD24Fc 480 mg arms, and at 366 days for the CD24Fc 960 mg arm.

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants Placebo to CD24Fc (saline IV injection solution) on day -1 or days -1, 14, and 28 + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)	CD24Fc 240 mg n=6 Participants CD24Fc in 240 mg as intravenous (IV) infusion at Day -1 + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)	CD24Fc 480 mg n=6 Participants CD24Fc in 480 mg as intravenous (IV) infusion at Day -1 + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)	CD24Fc 960 mg n=26 Participants CD24Fc (480 mg (day -1), 240 mg (day +14) and 240 mg (day +28)) + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)
Relapse-Free Survival (RFS) Following Hematopoietic Stem Cell Transplantation (HCT)	232.7 Days Standard Deviation 152.48	342.5 Days Standard Deviation 64.11	335.2 Days Standard Deviation 92.82	296.2 Days Standard Deviation 119.06

Adverse Events

Placebo

Serious events: 2 serious events

Other events: 6 other events

Deaths: 3 deaths

CD24Fc 240 mg

Serious events: 2 serious events

Other events: 6 other events

Deaths: 1 deaths

CD24Fc 480 mg

Serious events: 1 serious events

Other events: 6 other events

Deaths: 1 deaths

CD24Fc 960 mg (Multi-dose)

Serious events: 12 serious events

Other events: 26 other events

Deaths: 8 deaths

Serious adverse events

Other adverse events

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Placebo n=6 participants at risk Placebo to CD24Fc (saline IV injection solution) on day -1 or days -1, 14, and 28 + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)	CD24Fc 240 mg n=6 participants at risk CD24Fc in 240 mg as intravenous (IV) infusion at Day -1 + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)	CD24Fc 480 mg n=6 participants at risk CD24Fc in 480 mg as intravenous (IV) infusion at Day -1 + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)	CD24Fc 960 mg (Multi-dose) n=26 participants at risk CD24Fc (480 mg (day -1), 240 mg (day +14) and 240 mg (day +28)) + Tacrolimus (begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted) + Methotrexate (given intravenously at a dose of 15 mg/square meter/dose once daily on Day 1 after HCT, and at a dose of 10 mg/square meter/dose on days 3, 6, and 11 after HCT)
Gastrointestinal disorders Abdominal pain	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	3.8% 1/26 • Number of events 1 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.
Gastrointestinal disorders Nausea	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	16.7% 1/6 • Number of events 1 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	16.7% 1/6 • Number of events 1 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	7.7% 2/26 • Number of events 2 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.
Gastrointestinal disorders Stomatitis	16.7% 1/6 • Number of events 1 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	3.8% 1/26 • Number of events 1 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.
Gastrointestinal disorders Vomiting	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	3.8% 1/26 • Number of events 1 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.
Hepatobiliary disorders Venoocclusive liver disease	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	3.8% 1/26 • Number of events 1 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.
Immune system disorders Graft versus host disease in gastrointestinal tract	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	3.8% 1/26 • Number of events 1 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.
Immune system disorders Graft versus host disease in skin	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	3.8% 1/26 • Number of events 1 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.
Infections and infestations Cytomegalovirus infection	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	7.7% 2/26 • Number of events 2 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.
Infections and infestations Cytomegalovirus viraemia	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	3.8% 1/26 • Number of events 1 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.
Infections and infestations Device related infection	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	3.8% 1/26 • Number of events 1 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.
Infections and infestations Pneumonia	16.7% 1/6 • Number of events 2 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	0.00% 0/26 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.
Infections and infestations Stenotrophomonas infection	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	3.8% 1/26 • Number of events 1 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.
Infections and infestations Thrombophlebitis septic	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	3.8% 1/26 • Number of events 1 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.
Infections and infestations Upper respiratory tract infection	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	3.8% 1/26 • Number of events 1 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.
Infections and infestations Urinary tract infection	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	3.8% 1/26 • Number of events 1 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	3.8% 1/26 • Number of events 1 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.
Investigations Platelet count decreased	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	3.8% 1/26 • Number of events 1 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.
Investigations Weight decreased	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	16.7% 1/6 • Number of events 1 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	0.00% 0/26 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	16.7% 1/6 • Number of events 1 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	0.00% 0/26 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.
Metabolism and nutrition disorders Dehydration	16.7% 1/6 • Number of events 1 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	3.8% 1/26 • Number of events 1 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	16.7% 1/6 • Number of events 1 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	0.00% 0/26 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	3.8% 1/26 • Number of events 1 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.
Nervous system disorders Cognitive disorder	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	3.8% 1/26 • Number of events 1 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.
Nervous system disorders Somnolence	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	3.8% 1/26 • Number of events 1 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	3.8% 1/26 • Number of events 1 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.
Skin and subcutaneous tissue disorders Rash maculo-papular	16.7% 1/6 • Number of events 1 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	0.00% 0/26 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.
Skin and subcutaneous tissue disorders Stevens-Johnson syndrome	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	0.00% 0/6 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.	7.7% 2/26 • Number of events 2 • Up to 1134 days for All-Cause Mortality. Up to 1131 days for all adverse events.