Trial Outcomes & Findings for A Phase 2A Study of ALXN1007 in Participants With Newly Diagnosed Acute Lower Gastrointestinal Graft-Versus-Host Disease (NCT NCT02245412)

NCT ID: NCT02245412

Last Updated: 2019-01-03

Results Overview

The number of participants with overall acute GVHD response was determined at Day 28. Acute Overall GVHD is defined as improvement from diagnosis in any organ by at least 1 stage, without progression in any other organ, and with no additional therapy being administered. Acute GVHD staging included skin, liver, and GI assessments, which were to be performed using the Modified Keystone Grading Schema. Deaths were considered nonresponders; otherwise last postbaseline values were carried forward for imputation of missing responses. Modified Keystone Grading Schema: Skin - Stages 0 = No Rash, 1 = Rash \<25% body surface area (BSA), 2 = 25% to 50% BSA, 3 = \>50% BSA, 4 = bullae, desquamation; Lower GI Tract (stool volume over 24 hours) - Stages 0 = \<500 mL, 1 = 500 to 1000 mL, 2 = 1001 to 1500 mL, 3 = \>1500 mL, 4 = severe abdominal pain +/- ileus, frank blood, or melena; Liver (bilirubin levels) - Stages 0 = ≤2 mg/dL, 1 = 2.1 to 3 mg/dL, 2 = 3.1 to 6 mg/dL, 3 = 6.1 to 15 mg/dL, 4 = \>15 mg/dL.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 25 participants
• Primary outcome timeframe: Day 28
• Results posted on: 2019-01-03

Participant Flow

This study enrolled participants with newly diagnosed acute graft-versus-host disease (GVHD) of the lower gastrointestinal (GI) tract.

Participant milestones

Measure	ALXN1007 10 mg/kg Once Weekly Cohort 1, the first dosing cohort, received 10 milligrams/kilogram (mg/kg) ALXN1007 intravenously (IV) once weekly for 8 weeks.	ALXN1007 20 mg/kg Once Weekly Cohort 2 received 20 mg/kg ALXN1007 IV once weekly for 8 weeks. For the first 2 participants enrolled, the first ALXN1007 dose was not to be administered on the same day and a safety and tolerability review was to take place after the second (and prior to the third) ALXN1007 dose for each participant. If the ALXN1007 dose was determined to be sufficiently tolerated by the participant, dosing was to continue for that participant. For any other participants enrolled in the dosing cohort, participants were not to proceed to the third ALXN1007 dose prior to the completion of the safety and tolerability review (of the first 2 doses) for the first 2 participants.	ALXN1007 20 mg/kg Twice Weekly Cohort 3 received 20 mg/kg ALXN1007 IV twice weekly for 8 weeks. For the first 2 participants enrolled, the first ALXN1007 dose was not to be administered on the same day and a safety and tolerability review was to take place after the second (and prior to the third) ALXN1007 dose for each participant. If the ALXN1007 dose was determined to be sufficiently tolerated by the participant, dosing was to continue for that participant. For any other participants enrolled in the dosing cohort, participants were not to proceed to the third ALXN1007 dose prior to the completion of the safety and tolerability review (of the first 2 doses) for the first 2 participants.
Treatment Period STARTED	17	6	2
Treatment Period Received at Least 1 Dose of Study Drug	17	6	2
Treatment Period Modified Full Analysis Set (mFAS)	16	6	2
Treatment Period COMPLETED	12	3	2
Treatment Period NOT COMPLETED	5	3	0
Follow-Up Period STARTED	13	4	2
Follow-Up Period COMPLETED	8	2	0
Follow-Up Period NOT COMPLETED	5	2	2

Reasons for withdrawal

Measure	ALXN1007 10 mg/kg Once Weekly Cohort 1, the first dosing cohort, received 10 milligrams/kilogram (mg/kg) ALXN1007 intravenously (IV) once weekly for 8 weeks.	ALXN1007 20 mg/kg Once Weekly Cohort 2 received 20 mg/kg ALXN1007 IV once weekly for 8 weeks. For the first 2 participants enrolled, the first ALXN1007 dose was not to be administered on the same day and a safety and tolerability review was to take place after the second (and prior to the third) ALXN1007 dose for each participant. If the ALXN1007 dose was determined to be sufficiently tolerated by the participant, dosing was to continue for that participant. For any other participants enrolled in the dosing cohort, participants were not to proceed to the third ALXN1007 dose prior to the completion of the safety and tolerability review (of the first 2 doses) for the first 2 participants.	ALXN1007 20 mg/kg Twice Weekly Cohort 3 received 20 mg/kg ALXN1007 IV twice weekly for 8 weeks. For the first 2 participants enrolled, the first ALXN1007 dose was not to be administered on the same day and a safety and tolerability review was to take place after the second (and prior to the third) ALXN1007 dose for each participant. If the ALXN1007 dose was determined to be sufficiently tolerated by the participant, dosing was to continue for that participant. For any other participants enrolled in the dosing cohort, participants were not to proceed to the third ALXN1007 dose prior to the completion of the safety and tolerability review (of the first 2 doses) for the first 2 participants.
Treatment Period Death	1	1	0
Treatment Period Physician Decision	1	1	0
Treatment Period Withdrawal by Subject	2	1	0
Treatment Period Biopsy did not confirm GI GVHD	1	0	0
Follow-Up Period Death	4	2	1
Follow-Up Period Physician Decision	1	0	0
Follow-Up Period Other - Terminated by Sponsor	0	0	1

Baseline Characteristics

A Phase 2A Study of ALXN1007 in Participants With Newly Diagnosed Acute Lower Gastrointestinal Graft-Versus-Host Disease

Baseline characteristics by cohort

Measure	ALXN1007 10 mg/kg Once Weekly n=17 Participants Cohort 1, the first dosing cohort, received 10 mg/kg ALXN1007 IV once weekly for 8 weeks.	ALXN1007 20 mg/kg Once Weekly n=6 Participants Cohort 2 received 20 mg/kg ALXN1007 IV once weekly for 8 weeks. For the first 2 participants enrolled, the first ALXN1007 dose was not to be administered on the same day and a safety and tolerability review was to take place after the second (and prior to the third) ALXN1007 dose for each participant. If the ALXN1007 dose was determined to be sufficiently tolerated by the participant, dosing was to continue for that participant. For any other participants enrolled in the dosing cohort, participants were not to proceed to the third ALXN1007 dose prior to the completion of the safety and tolerability review (of the first 2 doses) for the first 2 participants.	ALXN1007 20 mg/kg Twice Weekly n=2 Participants Cohort 3 received 20 mg/kg ALXN1007 IV twice weekly for 8 weeks. For the first 2 participants enrolled, the first ALXN1007 dose was not to be administered on the same day and a safety and tolerability review was to take place after the second (and prior to the third) ALXN1007 dose for each participant. If the ALXN1007 dose was determined to be sufficiently tolerated by the participant, dosing was to continue for that participant. For any other participants enrolled in the dosing cohort, participants were not to proceed to the third ALXN1007 dose prior to the completion of the safety and tolerability review (of the first 2 doses) for the first 2 participants.	Total n=25 Participants Total of all reporting groups
Age, Continuous	54.6 years STANDARD_DEVIATION 14.27 • n=5 Participants	47.7 years STANDARD_DEVIATION 13.14 • n=7 Participants	70.5 years STANDARD_DEVIATION 2.12 • n=5 Participants	54.2 years STANDARD_DEVIATION 14.32 • n=4 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	11 Participants n=4 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	14 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	21 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	21 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment United States	16 participants n=5 Participants	6 participants n=7 Participants	2 participants n=5 Participants	24 participants n=4 Participants
Region of Enrollment France	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants
Acute GVHD Staging Skin · Staging Score 0	14 Participants n=5 Participants	6 Participants n=7 Participants	1 Participants n=5 Participants	21 Participants n=4 Participants
Acute GVHD Staging Skin · Staging Score 1	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Acute GVHD Staging Skin · Staging Score 2	3 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Acute GVHD Staging Skin · Staging Score 3	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Acute GVHD Staging Skin · Staging Score 4	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Acute GVHD Staging Lower GI Tract · Staging Score 0	7 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	7 Participants n=4 Participants
Acute GVHD Staging Lower GI Tract · Staging Score 1	4 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	6 Participants n=4 Participants
Acute GVHD Staging Lower GI Tract · Staging Score 2	1 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants
Acute GVHD Staging Lower GI Tract · Staging Score 3	5 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	7 Participants n=4 Participants
Acute GVHD Staging Lower GI Tract · Staging Score 4	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Acute GVHD Staging Liver · Staging Score 0	17 Participants n=5 Participants	6 Participants n=7 Participants	2 Participants n=5 Participants	25 Participants n=4 Participants
Acute GVHD Staging Liver · Staging Score 1	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Acute GVHD Staging Liver · Staging Score 2	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Acute GVHD Staging Liver · Staging Score 3	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Acute GVHD Staging Liver · Staging Score 4	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: Day 28

Population: Participants in the mFAS Population - In the 10 mg/kg ALXN1007 once weekly dose group, 1 participant was prematurely discontinued after receiving a single dose due to lack of confirmed GI GVHD.

The number of participants with overall acute GVHD response was determined at Day 28. Acute Overall GVHD is defined as improvement from diagnosis in any organ by at least 1 stage, without progression in any other organ, and with no additional therapy being administered. Acute GVHD staging included skin, liver, and GI assessments, which were to be performed using the Modified Keystone Grading Schema. Deaths were considered nonresponders; otherwise last postbaseline values were carried forward for imputation of missing responses. Modified Keystone Grading Schema: Skin - Stages 0 = No Rash, 1 = Rash <25% body surface area (BSA), 2 = 25% to 50% BSA, 3 = >50% BSA, 4 = bullae, desquamation; Lower GI Tract (stool volume over 24 hours) - Stages 0 = <500 mL, 1 = 500 to 1000 mL, 2 = 1001 to 1500 mL, 3 = >1500 mL, 4 = severe abdominal pain +/- ileus, frank blood, or melena; Liver (bilirubin levels) - Stages 0 = ≤2 mg/dL, 1 = 2.1 to 3 mg/dL, 2 = 3.1 to 6 mg/dL, 3 = 6.1 to 15 mg/dL, 4 = >15 mg/dL.

Outcome measures

Measure	ALXN1007 10 mg/kg Once Weekly n=16 Participants Cohort 1, the first dosing cohort, received 10 mg/kg ALXN1007 IV once weekly for 8 weeks.	ALXN1007 20 mg/kg Once Weekly n=6 Participants Cohort 2 received 20 mg/kg ALXN1007 IV once weekly for 8 weeks. For the first 2 participants enrolled, the first ALXN1007 dose was not to be administered on the same day and a safety and tolerability review was to take place after the second (and prior to the third) ALXN1007 dose for each participant. If the ALXN1007 dose was determined to be sufficiently tolerated by the participant, dosing was to continue for that participant. For any other participants enrolled in the dosing cohort, participants were not to proceed to the third ALXN1007 dose prior to the completion of the safety and tolerability review (of the first 2 doses) for the first 2 participants.	ALXN1007 20 mg/kg Twice Weekly n=2 Participants Cohort 3 received 20 mg/kg ALXN1007 IV twice weekly for 8 weeks. For the first 2 participants enrolled, the first ALXN1007 dose was not to be administered on the same day and a safety and tolerability review was to take place after the second (and prior to the third) ALXN1007 dose for each participant. If the ALXN1007 dose was determined to be sufficiently tolerated by the participant, dosing was to continue for that participant. For any other participants enrolled in the dosing cohort, participants were not to proceed to the third ALXN1007 dose prior to the completion of the safety and tolerability review (of the first 2 doses) for the first 2 participants.
Overall Acute Graft-Versus-Host Disease (GVHD) Response Rate At Day 28	10 Participants	3 Participants	1 Participants

SECONDARY outcome

Timeframe: Predose up to 72 hours postdose

Population: PK population: All participants in the 10 mg/kg ALXN1007 once weekly dose group who received at least 1 dose of ALXN1007 and who had evaluable PK and pharmacodynamic (PD) data.

The Tmax of ALXN1007 was measured on Treatment Days 1, 28, and 49, from blood samples collected at time points relative to the dosing of ALXN1007. PK assessments were to have been measured from Baseline, Treatment Days 7, 14, 21, 28, 35, 42, 49, 56, and Follow-up Days 86, 180, and Early Termination (ET).

Due to the early termination of the study and the clinical development of the ALXN1007 program, a number of PK analyses were not completed. PK data for the 20 mg/kg ALXN1007 once weekly dosing group and the 20 mg/kg ALXN1007 twice weekly dosing group are not available.

Outcome measures

Measure	ALXN1007 10 mg/kg Once Weekly n=10 Participants Cohort 1, the first dosing cohort, received 10 mg/kg ALXN1007 IV once weekly for 8 weeks.	ALXN1007 20 mg/kg Once Weekly Cohort 2 received 20 mg/kg ALXN1007 IV once weekly for 8 weeks. For the first 2 participants enrolled, the first ALXN1007 dose was not to be administered on the same day and a safety and tolerability review was to take place after the second (and prior to the third) ALXN1007 dose for each participant. If the ALXN1007 dose was determined to be sufficiently tolerated by the participant, dosing was to continue for that participant. For any other participants enrolled in the dosing cohort, participants were not to proceed to the third ALXN1007 dose prior to the completion of the safety and tolerability review (of the first 2 doses) for the first 2 participants.	ALXN1007 20 mg/kg Twice Weekly Cohort 3 received 20 mg/kg ALXN1007 IV twice weekly for 8 weeks. For the first 2 participants enrolled, the first ALXN1007 dose was not to be administered on the same day and a safety and tolerability review was to take place after the second (and prior to the third) ALXN1007 dose for each participant. If the ALXN1007 dose was determined to be sufficiently tolerated by the participant, dosing was to continue for that participant. For any other participants enrolled in the dosing cohort, participants were not to proceed to the third ALXN1007 dose prior to the completion of the safety and tolerability review (of the first 2 doses) for the first 2 participants.
Pharmacokinetics (PK): Time To Maximum Observed Concentration In Plasma (Tmax) Of IV ALXN1007 Tmax Day 1	1.033 hours Interval 0.983 to 5.0	—	—
Pharmacokinetics (PK): Time To Maximum Observed Concentration In Plasma (Tmax) Of IV ALXN1007 Tmax Day 28	1.03 hours Interval 1.0 to 5.0	—	—
Pharmacokinetics (PK): Time To Maximum Observed Concentration In Plasma (Tmax) Of IV ALXN1007 Tmax Day 49	1.25 hours Interval 1.0 to 1.8	—	—

SECONDARY outcome

Timeframe: Predose up to 72 hours postdose

Population: PK population: All participants in the 10 mg/kg ALXN1007 once weekly dose group who received at least 1 dose of ALXN1007 and who had evaluable PK and PD data.

The Cmax of ALXN1007 was measured on Treatment Days 1, 28, and 49, from blood samples collected at time points relative to the dosing of ALXN1007. PK assessments were to have been measured from Baseline, Treatment Days 7, 14, 21, 28, 35, 42, 49, 56, and Follow-up Days 86, 180, and Early Termination (ET).

Due to the early termination of the study and the clinical development of the ALXN1007 program, a number of PK analyses were not completed. PK data for the 20 mg/kg ALXN1007 once weekly dosing group and the 20 mg/kg ALXN1007 twice weekly dosing group are not available.

Outcome measures

Measure	ALXN1007 10 mg/kg Once Weekly n=10 Participants Cohort 1, the first dosing cohort, received 10 mg/kg ALXN1007 IV once weekly for 8 weeks.	ALXN1007 20 mg/kg Once Weekly Cohort 2 received 20 mg/kg ALXN1007 IV once weekly for 8 weeks. For the first 2 participants enrolled, the first ALXN1007 dose was not to be administered on the same day and a safety and tolerability review was to take place after the second (and prior to the third) ALXN1007 dose for each participant. If the ALXN1007 dose was determined to be sufficiently tolerated by the participant, dosing was to continue for that participant. For any other participants enrolled in the dosing cohort, participants were not to proceed to the third ALXN1007 dose prior to the completion of the safety and tolerability review (of the first 2 doses) for the first 2 participants.	ALXN1007 20 mg/kg Twice Weekly Cohort 3 received 20 mg/kg ALXN1007 IV twice weekly for 8 weeks. For the first 2 participants enrolled, the first ALXN1007 dose was not to be administered on the same day and a safety and tolerability review was to take place after the second (and prior to the third) ALXN1007 dose for each participant. If the ALXN1007 dose was determined to be sufficiently tolerated by the participant, dosing was to continue for that participant. For any other participants enrolled in the dosing cohort, participants were not to proceed to the third ALXN1007 dose prior to the completion of the safety and tolerability review (of the first 2 doses) for the first 2 participants.
PK: Maximum Observed Concentration In Plasma (Cmax) Of IV ALXN1007 Cmax Day 1	270 ug/mL Interval 156.0 to 318.0	—	—
PK: Maximum Observed Concentration In Plasma (Cmax) Of IV ALXN1007 Cmax Day 28	383 ug/mL Interval 283.0 to 409.0	—	—
PK: Maximum Observed Concentration In Plasma (Cmax) Of IV ALXN1007 Cmax Day 49	421 ug/mL Interval 207.0 to 450.0	—	—

SECONDARY outcome

Timeframe: Predose up to 72 hours postdose

Population: PK population: All participants in the 10 mg/kg ALXN1007 once weekly dose group who received at least 1 dose of ALXN1007 and who had evaluable PK and PD data.

The AUC of ALXN1007 was measured on Treatment Days 1, 28, and 49, from blood samples collected at time points relative to the dosing of ALXN1007. PK assessments were to have been measured from Baseline, Treatment Days 7, 14, 21, 28, 35, 42, 49, 56, and Follow-up Days 86, 180, and Early Termination (ET).

Due to the early termination of the study and the clinical development of the ALXN1007 program, a number of PK analyses were not completed. PK data for the 20 mg/kg ALXN1007 once weekly dosing group and the 20 mg/kg ALXN1007 twice weekly dosing group are not available.

Outcome measures

Measure	ALXN1007 10 mg/kg Once Weekly n=10 Participants Cohort 1, the first dosing cohort, received 10 mg/kg ALXN1007 IV once weekly for 8 weeks.	ALXN1007 20 mg/kg Once Weekly Cohort 2 received 20 mg/kg ALXN1007 IV once weekly for 8 weeks. For the first 2 participants enrolled, the first ALXN1007 dose was not to be administered on the same day and a safety and tolerability review was to take place after the second (and prior to the third) ALXN1007 dose for each participant. If the ALXN1007 dose was determined to be sufficiently tolerated by the participant, dosing was to continue for that participant. For any other participants enrolled in the dosing cohort, participants were not to proceed to the third ALXN1007 dose prior to the completion of the safety and tolerability review (of the first 2 doses) for the first 2 participants.	ALXN1007 20 mg/kg Twice Weekly Cohort 3 received 20 mg/kg ALXN1007 IV twice weekly for 8 weeks. For the first 2 participants enrolled, the first ALXN1007 dose was not to be administered on the same day and a safety and tolerability review was to take place after the second (and prior to the third) ALXN1007 dose for each participant. If the ALXN1007 dose was determined to be sufficiently tolerated by the participant, dosing was to continue for that participant. For any other participants enrolled in the dosing cohort, participants were not to proceed to the third ALXN1007 dose prior to the completion of the safety and tolerability review (of the first 2 doses) for the first 2 participants.
PK: Area Under The Plasma (Or Serum) Concentration Versus Time Curve (AUC) Of IV ALXN1007 AUC Day 1	13079 h*ug/mL Interval 7429.0 to 20113.0	—	—
PK: Area Under The Plasma (Or Serum) Concentration Versus Time Curve (AUC) Of IV ALXN1007 AUC Day 28	34957 h*ug/mL Interval 22432.0 to 50439.0	—	—
PK: Area Under The Plasma (Or Serum) Concentration Versus Time Curve (AUC) Of IV ALXN1007 AUC Day 49	41919 h*ug/mL Interval 17182.0 to 59625.0	—	—

Adverse Events

ALXN1007 10 mg/kg Once Weekly

Serious events: 13 serious events

Other events: 17 other events

Deaths: 6 deaths

ALXN1007 20 mg/kg Once Weekly

Serious events: 4 serious events

Other events: 6 other events

Deaths: 3 deaths

ALXN1007 20 mg/kg Twice Weekly

Serious events: 2 serious events

Other events: 2 other events

Deaths: 1 deaths

Serious adverse events

Measure	ALXN1007 10 mg/kg Once Weekly n=17 participants at risk Cohort 1, the first dosing cohort, received 10 mg/kg ALXN1007 IV once weekly for 8 weeks.	ALXN1007 20 mg/kg Once Weekly n=6 participants at risk Cohort 2 received 20 mg/kg ALXN1007 IV once weekly for 8 weeks. For the first 2 participants enrolled, the first ALXN1007 dose was not to be administered on the same day and a safety and tolerability review was to take place after the second (and prior to the third) ALXN1007 dose for each participant. If the ALXN1007 dose was determined to be sufficiently tolerated by the participant, dosing was to continue for that participant. For any other participants enrolled in the dosing cohort, participants were not to proceed to the third ALXN1007 dose prior to the completion of the safety and tolerability review (of the first 2 doses) for the first 2 participants.	ALXN1007 20 mg/kg Twice Weekly n=2 participants at risk Cohort 3 received 20 mg/kg ALXN1007 IV twice weekly for 8 weeks. For the first 2 participants enrolled, the first ALXN1007 dose was not to be administered on the same day and a safety and tolerability review was to take place after the second (and prior to the third) ALXN1007 dose for each participant. If the ALXN1007 dose was determined to be sufficiently tolerated by the participant, dosing was to continue for that participant. For any other participants enrolled in the dosing cohort, participants were not to proceed to the third ALXN1007 dose prior to the completion of the safety and tolerability review (of the first 2 doses) for the first 2 participants.
Blood and lymphatic system disorders Febrile neutropenia	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Blood and lymphatic system disorders Thrombotic microangiopathy	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Gastrointestinal disorders Ascites	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Gastrointestinal disorders Chronic gastritis	0.00% 0/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	16.7% 1/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Gastrointestinal disorders Diarrhoea	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Gastrointestinal disorders Large intestine perforation	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Gastrointestinal disorders Nausea	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Gastrointestinal disorders Rectal haemorrhage	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Gastrointestinal disorders Vomiting	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
General disorders Asthenia	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
General disorders Chest pain	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
General disorders Influenza like illness	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
General disorders Multiple organ dysfunction syndrome	0.00% 0/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	50.0% 1/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Immune system disorders Graft versus host disease	0.00% 0/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	16.7% 1/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	50.0% 1/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Immune system disorders Graft versus host disease in gastrointestinal tract	23.5% 4/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	33.3% 2/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	100.0% 2/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Infections and infestations BK virus infection	11.8% 2/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Infections and infestations Cellulitis	0.00% 0/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	50.0% 1/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Infections and infestations Cytomegalovirus viraemia	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Infections and infestations Device related infection	64.7% 11/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Infections and infestations Encephalitis	0.00% 0/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	16.7% 1/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Infections and infestations Pneumonia	0.00% 0/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	16.7% 1/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Infections and infestations Respiratory syncytial virus infection	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Infections and infestations Staphylococcal infection	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Infections and infestations Urinary tract infection	0.00% 0/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	50.0% 1/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Injury, poisoning and procedural complications Post procedural complication	0.00% 0/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	16.7% 1/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Injury, poisoning and procedural complications Subdural haematoma	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Musculoskeletal and connective tissue disorders Back pain	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	17.6% 3/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Precursor B-lymphoblastic lymphoma recurrent	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) T-cell lymphoma recurrent	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Nervous system disorders Syncope	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Psychiatric disorders Mental status changes	11.8% 2/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.

Other adverse events

Measure	ALXN1007 10 mg/kg Once Weekly n=17 participants at risk Cohort 1, the first dosing cohort, received 10 mg/kg ALXN1007 IV once weekly for 8 weeks.	ALXN1007 20 mg/kg Once Weekly n=6 participants at risk Cohort 2 received 20 mg/kg ALXN1007 IV once weekly for 8 weeks. For the first 2 participants enrolled, the first ALXN1007 dose was not to be administered on the same day and a safety and tolerability review was to take place after the second (and prior to the third) ALXN1007 dose for each participant. If the ALXN1007 dose was determined to be sufficiently tolerated by the participant, dosing was to continue for that participant. For any other participants enrolled in the dosing cohort, participants were not to proceed to the third ALXN1007 dose prior to the completion of the safety and tolerability review (of the first 2 doses) for the first 2 participants.	ALXN1007 20 mg/kg Twice Weekly n=2 participants at risk Cohort 3 received 20 mg/kg ALXN1007 IV twice weekly for 8 weeks. For the first 2 participants enrolled, the first ALXN1007 dose was not to be administered on the same day and a safety and tolerability review was to take place after the second (and prior to the third) ALXN1007 dose for each participant. If the ALXN1007 dose was determined to be sufficiently tolerated by the participant, dosing was to continue for that participant. For any other participants enrolled in the dosing cohort, participants were not to proceed to the third ALXN1007 dose prior to the completion of the safety and tolerability review (of the first 2 doses) for the first 2 participants.
Blood and lymphatic system disorders Anaemia	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	16.7% 1/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Blood and lymphatic system disorders Febrile neutropenia	11.8% 2/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Blood and lymphatic system disorders Leukocytosis	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Blood and lymphatic system disorders Lymphopenia	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Blood and lymphatic system disorders Neutropenia	11.8% 2/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	16.7% 1/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	16.7% 1/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Blood and lymphatic system disorders Thrombocytopenia	11.8% 2/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	16.7% 1/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	50.0% 1/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Cardiac disorders Atrial fibrillation	0.00% 0/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	50.0% 1/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Cardiac disorders Atrial flutter	0.00% 0/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	50.0% 1/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Cardiac disorders Bradycardia	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Cardiac disorders Sinus tachycardia	0.00% 0/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	16.7% 1/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Cardiac disorders Tachycardia	0.00% 0/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	16.7% 1/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	50.0% 1/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Ear and labyrinth disorders Tinnitus	0.00% 0/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	16.7% 1/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Eye disorders Dry eye	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Eye disorders Eye pain	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Eye disorders Eyelid margin crusting	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Eye disorders Scleral hyperaemia	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Eye disorders Vision blurred	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Eye disorders Visual impairment	0.00% 0/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	16.7% 1/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Eye disorders Vitreous degeneration	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Eye disorders Vitreous detachment	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Gastrointestinal disorders Abdominal distension	11.8% 2/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Gastrointestinal disorders Abdominal pain	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	16.7% 1/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Gastrointestinal disorders Abdominal pain upper	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Gastrointestinal disorders Anal incontinence	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Gastrointestinal disorders Ascites	11.8% 2/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Gastrointestinal disorders Constipation	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Gastrointestinal disorders Diarrhoea	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Gastrointestinal disorders Dry mouth	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	16.7% 1/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Gastrointestinal disorders Dyspepsia	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Gastrointestinal disorders Flatulence	0.00% 0/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	16.7% 1/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Gastrointestinal disorders Gastrointestinal haemorrhage	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Gastrointestinal disorders Haemorrhoids	0.00% 0/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	16.7% 1/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	50.0% 1/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Gastrointestinal disorders Ileus	0.00% 0/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	16.7% 1/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Gastrointestinal disorders Impaired gastric emptying	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Gastrointestinal disorders Inguinal hernia	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Gastrointestinal disorders Intestinal obstruction	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Gastrointestinal disorders Nausea	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	16.7% 1/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Gastrointestinal disorders Small intestinal obstruction	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Gastrointestinal disorders Stomatitis	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Gastrointestinal disorders Vomiting	0.00% 0/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	16.7% 1/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
General disorders Asthenia	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	50.0% 1/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
General disorders Chest pain	11.8% 2/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
General disorders Chills	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
General disorders Device related thrombosis	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
General disorders Fatigue	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	16.7% 1/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	50.0% 1/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
General disorders Oedema	11.8% 2/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	16.7% 1/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
General disorders Oedema peripheral	41.2% 7/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	33.3% 2/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	50.0% 1/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
General disorders Peripheral swelling	0.00% 0/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	50.0% 1/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
General disorders Pyrexia	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	16.7% 1/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Hepatobiliary disorders Hyperbilirubinaemia	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	33.3% 2/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Hepatobiliary disorders Jaundice	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Immune system disorders Graft versus host disease in skin	0.00% 0/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	16.7% 1/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Immune system disorders Hypersensitivity	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	16.7% 1/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Immune system disorders Hypogammaglobulinaemia	0.00% 0/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	16.7% 1/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	50.0% 1/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Infections and infestations Adenovirus infection	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	16.7% 1/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Infections and infestations BK virus infection	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	16.7% 1/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Infections and infestations Bacteraemia	0.00% 0/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	16.7% 1/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Infections and infestations Bronchopulmonary aspergillosis	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Infections and infestations Candida infection	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Infections and infestations Cellulitis	0.00% 0/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	50.0% 1/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Infections and infestations Colitis herpes	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Infections and infestations Corona virus infection	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Infections and infestations Cytomegalovirus colitis	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Infections and infestations Cytomegalovirus infection	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	16.7% 1/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Infections and infestations Cytomegalovirus viraemia	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	16.7% 1/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Infections and infestations Enterococcal bacteraemia	0.00% 0/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	50.0% 1/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Infections and infestations Enterococcal infection	11.8% 2/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	16.7% 1/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Infections and infestations Epstein-Barr viraemia	0.00% 0/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	50.0% 1/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Infections and infestations Epstein-Barr virus infection	11.8% 2/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	16.7% 1/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Infections and infestations Folliculitis	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Infections and infestations Human herpesvirus 6 infection	11.8% 2/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Infections and infestations Infection	0.00% 0/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	16.7% 1/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Infections and infestations Influenza	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Infections and infestations Pneumonia	0.00% 0/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	16.7% 1/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Infections and infestations Respiratory syncytial virus infection	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Infections and infestations Rotavirus infection	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Infections and infestations Sepsis	0.00% 0/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	50.0% 1/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Infections and infestations Sinusitis	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Infections and infestations Staphylococcal bacteraemia	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Infections and infestations Staphylococcal infection	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Infections and infestations Urinary tract infection	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	16.7% 1/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	50.0% 1/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Infections and infestations Urinary tract infection enterococcal	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Infections and infestations Urinary tract infection staphylococcal	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Injury, poisoning and procedural complications Contusion	11.8% 2/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Injury, poisoning and procedural complications Fall	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	50.0% 1/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Injury, poisoning and procedural complications Infusion related reaction	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Injury, poisoning and procedural complications Thermal burn	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Injury, poisoning and procedural complications Wound	0.00% 0/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	50.0% 1/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Investigations Alanine aminotransferase increased	11.8% 2/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	16.7% 1/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Investigations Aspartate aminotransferase increased	11.8% 2/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	16.7% 1/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Investigations Blood alkaline phosphatase increased	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Investigations Blood creatinine increased	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	16.7% 1/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Investigations Blood immunoglobulin G decreased	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Investigations Lymphocyte count decreased	0.00% 0/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	16.7% 1/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Investigations Neutrophil count decreased	0.00% 0/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	16.7% 1/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	50.0% 1/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Investigations Transaminases increased	0.00% 0/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	16.7% 1/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Investigations Weight decreased	0.00% 0/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	33.3% 2/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Investigations White blood cell count decreased	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	50.0% 3/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Investigations White blood cell count increased	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	16.7% 1/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Metabolism and nutrition disorders Dehydration	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Metabolism and nutrition disorders Diabetes mellitus	11.8% 2/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Metabolism and nutrition disorders Fluid overload	11.8% 2/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	16.7% 1/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Metabolism and nutrition disorders Glucose tolerance impaired	0.00% 0/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	16.7% 1/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Metabolism and nutrition disorders Hyperglycaemia	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	33.3% 2/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	50.0% 1/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	33.3% 2/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	16.7% 1/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Metabolism and nutrition disorders Hypocalcaemia	17.6% 3/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Metabolism and nutrition disorders Hypokalaemia	11.8% 2/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	16.7% 1/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	50.0% 1/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Metabolism and nutrition disorders Hypomagnesaemia	11.8% 2/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Metabolism and nutrition disorders Hypophosphataemia	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	16.7% 1/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	16.7% 1/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Musculoskeletal and connective tissue disorders Arthralgia	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Musculoskeletal and connective tissue disorders Muscle spasms	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Musculoskeletal and connective tissue disorders Muscular weakness	11.8% 2/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	50.0% 1/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	16.7% 1/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	50.0% 1/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Nervous system disorders Akathisia	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Nervous system disorders Dizziness	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	50.0% 1/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Nervous system disorders Dysgeusia	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	16.7% 1/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Nervous system disorders Headache	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Nervous system disorders Lethargy	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Nervous system disorders Paraesthesia	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Nervous system disorders Somnolence	0.00% 0/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	50.0% 1/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Nervous system disorders Tardive dyskinesia	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Nervous system disorders Tremor	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Psychiatric disorders Agitation	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Psychiatric disorders Anxiety	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Psychiatric disorders Confusional state	17.6% 3/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Psychiatric disorders Depression	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Psychiatric disorders Depressive symptom	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Psychiatric disorders Hallucination, visual	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Psychiatric disorders Insomnia	11.8% 2/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	16.7% 1/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Renal and urinary disorders Acute kidney injury	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Renal and urinary disorders Micturition urgency	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Renal and urinary disorders Urinary incontinence	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Reproductive system and breast disorders Vulvovaginal discomfort	0.00% 0/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	16.7% 1/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Respiratory, thoracic and mediastinal disorders Cough	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Respiratory, thoracic and mediastinal disorders Dysphonia	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	33.3% 2/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Respiratory, thoracic and mediastinal disorders Hypoxia	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Respiratory, thoracic and mediastinal disorders Nasal dryness	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	16.7% 1/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	16.7% 1/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.00% 0/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	16.7% 1/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Skin and subcutaneous tissue disorders Decubitus ulcer	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	16.7% 1/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	16.7% 1/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Skin and subcutaneous tissue disorders Dry skin	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Skin and subcutaneous tissue disorders Erythema	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Skin and subcutaneous tissue disorders Pruritus generalised	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Skin and subcutaneous tissue disorders Rash	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Skin and subcutaneous tissue disorders Skin lesion	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	50.0% 1/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Vascular disorders Deep vein thrombosis	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	16.7% 1/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Vascular disorders Haematoma	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Vascular disorders Hypertension	17.6% 3/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	50.0% 1/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Vascular disorders Hypotension	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	16.7% 1/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	50.0% 1/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Metabolism and nutrition disorders Hypoglycaemia	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.
Infections and infestations Cystitis viral	5.9% 1/17 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/6 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.	0.00% 0/2 • Up to 1 year Adverse Events were reported for the mFAS, which included all participants who received at least 1 dose of ALXN1007 and for whom GI GVHD was confirmed through biopsy.

Additional Information

Alexion Pharmaceuticals Inc.

Alexion Pharmaceuticals Inc.

Phone: 855-752-2356

Email: clinicaltrials@alexion.com

Results disclosure agreements

• Principal investigator is a sponsor employee Publication rights are tied to the completion of the multi-center publication
• Publication restrictions are in place

Restriction type: OTHER