Trial Outcomes & Findings for Dose Finding Study of Vedolizumab for GvHD in Participants Undergoing Allogeneic HSCT (NCT NCT02728895)

NCT ID: NCT02728895

Last Updated: 2019-08-26

Results Overview

DLTs was based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 and was defined as any of following events: Grade 3 or higher toxicity assessed by the investigator as related to vedolizumab treatment; Grade 4 or higher regimen-related organ toxicities; and failure to engraft by Day +28. Engraftment was defined as absolute neutrophils count (ANC) greater than (\>) 500 per cubic millimeter (/mm\^3) for 3 consecutive days or \>2000/mm\^3 for 1 day.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 24 participants
• Primary outcome timeframe: Baseline up to Day 28
• Results posted on: 2019-08-26

Participant Flow

Participants took part in the study at 5 investigative sites in the United States from 15 June 2016 to 10 July 2018.

Participants undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT) were enrolled to receive vedolizumab intravenous 75 milligram (mg) or 300 mg along with standard graft-versus-host disease (GvHD) prophylaxis therapy (tacrolimus plus short team methotrexate).

Participant milestones

Measure	Cohort 1: Vedolizumab 75 mg Vedolizumab 75 mg, 30-minutes infusion, intravenously, once on Day -1 (before allo-HSCT on Day 1), and Days 13 and 42 (after allo-HSCT on Day 1).	Cohort 2: Vedolizumab 300 mg Vedolizumab 300 mg, 30-minutes infusion, intravenously once on Days -1 (before allo-HSCT on Day 1), and Days 13 and 42 (after allo-HSCT on Day 1).
Overall Study STARTED	3	21
Overall Study COMPLETED	2	16
Overall Study NOT COMPLETED	1	5

Reasons for withdrawal

Measure	Cohort 1: Vedolizumab 75 mg Vedolizumab 75 mg, 30-minutes infusion, intravenously, once on Day -1 (before allo-HSCT on Day 1), and Days 13 and 42 (after allo-HSCT on Day 1).	Cohort 2: Vedolizumab 300 mg Vedolizumab 300 mg, 30-minutes infusion, intravenously once on Days -1 (before allo-HSCT on Day 1), and Days 13 and 42 (after allo-HSCT on Day 1).
Overall Study Other	1	2
Overall Study Withdrawal by Subject	0	3

Baseline Characteristics

Dose Finding Study of Vedolizumab for GvHD in Participants Undergoing Allogeneic HSCT

Baseline characteristics by cohort

Measure	Cohort 1: Vedolizumab 75 mg n=3 Participants Vedolizumab 75 mg, 30-minutes infusion, intravenously, once on Day -1 (before allo-HSCT on Day 1), and Days 13 and 42 (after allo-HSCT on Day 1).	Cohort 2: Vedolizumab 300 mg n=21 Participants Vedolizumab 300 mg, 30-minutes infusion, intravenously once on Days -1 (before allo-HSCT on Day 1), and Days 13 and 42 (after allo-HSCT on Day 1).	Total n=24 Participants Total of all reporting groups
Age, Continuous	30.0 years STANDARD_DEVIATION 17.44 • n=5 Participants	52.7 years STANDARD_DEVIATION 16.90 • n=7 Participants	49.9 years STANDARD_DEVIATION 18.27 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	16 Participants n=7 Participants	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	18 Participants n=7 Participants	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 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
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	19 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	3 Participants n=5 Participants	21 Participants n=7 Participants	24 Participants n=5 Participants
Weight	92.93 kilogram (kg) STANDARD_DEVIATION 25.662 • n=5 Participants	89.96 kilogram (kg) STANDARD_DEVIATION 25.836 • n=7 Participants	90.33 kilogram (kg) STANDARD_DEVIATION 25.272 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline up to Day 28

Population: The population of participants evaluable for vedolizumab safety was defined as all participants who received any amount of vedolizumab intravenously.

DLTs was based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 and was defined as any of following events: Grade 3 or higher toxicity assessed by the investigator as related to vedolizumab treatment; Grade 4 or higher regimen-related organ toxicities; and failure to engraft by Day +28. Engraftment was defined as absolute neutrophils count (ANC) greater than (>) 500 per cubic millimeter (/mm^3) for 3 consecutive days or >2000/mm^3 for 1 day.

Outcome measures

Measure	Cohort 1: Vedolizumab 75 mg n=3 Participants Vedolizumab 75 mg, 30-minutes infusion, intravenously, once on Day -1 (before allo-HSCT on Day 1), and Days 13 and 42 (after allo-HSCT on Day 1).	Cohort 2: Vedolizumab 300 mg n=21 Participants Vedolizumab 300 mg, 30-minutes infusion, intravenously once on Days -1 (before allo-HSCT on Day 1), and Days 13 and 42 (after allo-HSCT on Day 1).
Number of Participants With Dose-Limiting Toxicities (DLTs)	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 18 weeks after last dose of study drug

Population: The population of participants evaluable for vedolizumab safety was defined as all participants who received any amount of vedolizumab intravenously.

Outcome measures

Measure	Cohort 1: Vedolizumab 75 mg n=3 Participants Vedolizumab 75 mg, 30-minutes infusion, intravenously, once on Day -1 (before allo-HSCT on Day 1), and Days 13 and 42 (after allo-HSCT on Day 1).	Cohort 2: Vedolizumab 300 mg n=21 Participants Vedolizumab 300 mg, 30-minutes infusion, intravenously once on Days -1 (before allo-HSCT on Day 1), and Days 13 and 42 (after allo-HSCT on Day 1).
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) TEAEs	3 Participants	21 Participants
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) SAEs	2 Participants	11 Participants

PRIMARY outcome

Timeframe: Day 100

Population: The pharmacokinetic (PK) population was defined as participants from the safety set with at least 1 PK sample collected. The PK population where data at specified time points was available.

Outcome measures

Measure	Cohort 1: Vedolizumab 75 mg n=2 Participants Vedolizumab 75 mg, 30-minutes infusion, intravenously, once on Day -1 (before allo-HSCT on Day 1), and Days 13 and 42 (after allo-HSCT on Day 1).	Cohort 2: Vedolizumab 300 mg n=18 Participants Vedolizumab 300 mg, 30-minutes infusion, intravenously once on Days -1 (before allo-HSCT on Day 1), and Days 13 and 42 (after allo-HSCT on Day 1).
Mean Serum Concentrations of Vedolizumab That Helped the Likelihood of Alpha4Beta7 Target Saturation on Day 100 Following Allo-HSCT	7.34 microgram per milliliter (mcg/mL) Standard Deviation 3.762	18.36 microgram per milliliter (mcg/mL) Standard Deviation 11.043

SECONDARY outcome

Timeframe: Baseline up to Day 100

Population: The population of participants evaluable for vedolizumab safety was defined as all participants who received any amount of vedolizumab intravenously.

Time to neutrophil engraftment (recovery of ANC) was defined by an ANC >500/mm^3 for 3 consecutive days or >2000/mm^3 for 1 day. Time to neutrophil engraftment was calculated using Kaplan-Meier estimate and presented with 2-sided 95% confidence interval.

Outcome measures

Measure	Cohort 1: Vedolizumab 75 mg n=3 Participants Vedolizumab 75 mg, 30-minutes infusion, intravenously, once on Day -1 (before allo-HSCT on Day 1), and Days 13 and 42 (after allo-HSCT on Day 1).	Cohort 2: Vedolizumab 300 mg n=21 Participants Vedolizumab 300 mg, 30-minutes infusion, intravenously once on Days -1 (before allo-HSCT on Day 1), and Days 13 and 42 (after allo-HSCT on Day 1).
Time to Neutrophil Engraftment	22 days Interval 15.0 to 22.0	14 days Interval 13.0 to 17.0

SECONDARY outcome

Timeframe: Baseline up to Day 100

Population: The population of participants evaluable for vedolizumab safety was defined as all participants who received any amount of vedolizumab intravenously.

GvHD grading scale was based on the modified Glucksberg criteria. The grades are defined as: Grade 1 (skin stage 1 or 2 only); Grade 2 (skin stage 3 or liver stage 1 or lower or gastrointestinal [GI] stage 1 or upper GI involvement); Grade 3 (skin stage 0 to 3 plus liver stage 2 to 4 or lower GI stage 2 to 3); Grade 4 (skin stage 4 or lower GI stage 4).

Outcome measures

Measure	Cohort 1: Vedolizumab 75 mg n=3 Participants Vedolizumab 75 mg, 30-minutes infusion, intravenously, once on Day -1 (before allo-HSCT on Day 1), and Days 13 and 42 (after allo-HSCT on Day 1).	Cohort 2: Vedolizumab 300 mg n=21 Participants Vedolizumab 300 mg, 30-minutes infusion, intravenously once on Days -1 (before allo-HSCT on Day 1), and Days 13 and 42 (after allo-HSCT on Day 1).
Percentage of Participants With Overall Grade 2 to 4 Acute Graft-Versus-Host Disease (GvHD)	0 percentage of participants Interval 0.0 to 70.8	19.0 percentage of participants Interval 5.4 to 41.9

SECONDARY outcome

Timeframe: Baseline up to Day 100

Population: The population of participants evaluable for vedolizumab safety was defined as all participants who received any amount of vedolizumab intravenously.

Maximum severity was assessed using GvHD grading scale based on the modified Glucksberg criteria. The grades are defined as: Grade 1 (skin stage 1 or 2 only); Grade 2 (skin stage 3 or liver stage 1 or lower or GI stage 1 or upper GI involvement); Grade 3 (skin stage 0 to 3 plus liver stage 2 to 4 or lower GI stage 2 to 3); Grade 4 (skin stage 4 or lower GI stage 4).

Outcome measures

Measure	Cohort 1: Vedolizumab 75 mg n=3 Participants Vedolizumab 75 mg, 30-minutes infusion, intravenously, once on Day -1 (before allo-HSCT on Day 1), and Days 13 and 42 (after allo-HSCT on Day 1).	Cohort 2: Vedolizumab 300 mg n=21 Participants Vedolizumab 300 mg, 30-minutes infusion, intravenously once on Days -1 (before allo-HSCT on Day 1), and Days 13 and 42 (after allo-HSCT on Day 1).
Percentage of Participants With Maximum Severity of Acute GvHD Based on Modified Glucksberg Criteria Grade 2	0 percentage of participants Upper limit and lower limit of confidence interval could not be calculated because no participants had Grade 2 severity.	14.3 percentage of participants Interval 3.8 to 41.1
Percentage of Participants With Maximum Severity of Acute GvHD Based on Modified Glucksberg Criteria Grade 3	0 percentage of participants Upper limit and lower limit of confidence interval could not be calculated because no participants had Grade 3 severity.	4.8 percentage of participants Interval 0.6 to 29.7
Percentage of Participants With Maximum Severity of Acute GvHD Based on Modified Glucksberg Criteria Grade 4	0 percentage of participants Upper limit and lower limit of confidence interval could not be calculated because no participants had Grade 4 severity.	0 percentage of participants Upper limit and lower limit of confidence interval could not be calculated because no participants had Grade 4 severity.
Percentage of Participants With Maximum Severity of Acute GvHD Based on Modified Glucksberg Criteria Grade 1	66.7 percentage of participants Interval 17.5 to 95.0	28.6 percentage of participants Interval 11.3 to 55.6

SECONDARY outcome

Timeframe: Baseline up to Day 100

Population: The population of participants evaluable for vedolizumab safety was defined as all participants who received any amount of vedolizumab intravenously.

Maximum severity of acute GvHD was assessed by using BMT CTN modified IBMTR index. The severity index are defined as: Grade A (skin stage 1: extent of rash less than [<] 25%); Grade B (skin stage 2: extent of rash 25 to 50% or liver stage 1 to 2: total bilirubin 34 to 102 micromole per liter [mcmol/L] or intestinal tract stage 1 to 2: volume of diarrhea 550 to 1500 milliliter per day [mL/day]); Grade C (skin stage 3: extent of rash greater than (>) 50% or liver stage 3: total bilirubin 103 to 255 mcmol/L or intestinal tract stage 3: volume of diarrhea >1500 mL/day); Grade D (skin stage 4: extent of rash bullae or liver stage 4: total bilirubin >255 or intestinal tract stage 4: volume of diarrhea severe pain and ileus).

Outcome measures

Measure	Cohort 1: Vedolizumab 75 mg n=3 Participants Vedolizumab 75 mg, 30-minutes infusion, intravenously, once on Day -1 (before allo-HSCT on Day 1), and Days 13 and 42 (after allo-HSCT on Day 1).	Cohort 2: Vedolizumab 300 mg n=21 Participants Vedolizumab 300 mg, 30-minutes infusion, intravenously once on Days -1 (before allo-HSCT on Day 1), and Days 13 and 42 (after allo-HSCT on Day 1).
Percentage of Participants With Maximum Severity of Acute GvHD Based on Blood and Marrow Transplant Clinical Trials Network (BMT CTN) Modified International Bone Marrow Transplant Registry Database (IBMTR) Index Grade A	0 percentage of participants Upper limit and lower limit of confidence interval could not be calculated because no participants had Grade A severity.	19.0 percentage of participants Interval 6.1 to 46.2
Percentage of Participants With Maximum Severity of Acute GvHD Based on Blood and Marrow Transplant Clinical Trials Network (BMT CTN) Modified International Bone Marrow Transplant Registry Database (IBMTR) Index Grade B	66.7 percentage of participants Interval 17.5 to 95.0	14.3 percentage of participants Interval 3.8 to 41.1
Percentage of Participants With Maximum Severity of Acute GvHD Based on Blood and Marrow Transplant Clinical Trials Network (BMT CTN) Modified International Bone Marrow Transplant Registry Database (IBMTR) Index Grade C	0 percentage of participants Upper limit and lower limit of confidence interval could not be calculated because no participants had Grade C severity.	14.3 percentage of participants Interval 3.8 to 41.1
Percentage of Participants With Maximum Severity of Acute GvHD Based on Blood and Marrow Transplant Clinical Trials Network (BMT CTN) Modified International Bone Marrow Transplant Registry Database (IBMTR) Index Grade D	0 percentage of participants Upper limit and lower limit of confidence interval could not be calculated because no participants had Grade D severity.	0 percentage of participants Upper limit and lower limit of confidence interval could not be calculated because no participants had Grade D severity.

SECONDARY outcome

Timeframe: Days 13 and 42 pre-dose

Population: The PK population was defined as participants from the safety set with at least 1 PK sample collected. The PK population where data at specified time points was available.

Outcome measures

Measure	Cohort 1: Vedolizumab 75 mg n=3 Participants Vedolizumab 75 mg, 30-minutes infusion, intravenously, once on Day -1 (before allo-HSCT on Day 1), and Days 13 and 42 (after allo-HSCT on Day 1).	Cohort 2: Vedolizumab 300 mg n=21 Participants Vedolizumab 300 mg, 30-minutes infusion, intravenously once on Days -1 (before allo-HSCT on Day 1), and Days 13 and 42 (after allo-HSCT on Day 1).
Ctrough: Serum Concentration Before Dosing for Vedolizumab Day 13	5.87 mcg/mL Standard Deviation 3.00	21.34 mcg/mL Standard Deviation 6.05
Ctrough: Serum Concentration Before Dosing for Vedolizumab Day 42	8.17 mcg/mL Standard Deviation 5.20	29.05 mcg/mL Standard Deviation 13.04

Adverse Events

Cohort 1: Vedolizumab 75 mg

Serious events: 2 serious events

Other events: 3 other events

Deaths: 1 deaths

Cohort 2: Vedolizumab 300 mg

Serious events: 11 serious events

Other events: 21 other events

Deaths: 2 deaths

Serious adverse events

Measure	Cohort 1: Vedolizumab 75 mg n=3 participants at risk Vedolizumab 75 mg, 30-minutes infusion, intravenously, once on Day -1 (before allo-HSCT on Day 1), and Days 13 and 42 (after allo-HSCT on Day 1).	Cohort 2: Vedolizumab 300 mg n=21 participants at risk Vedolizumab 300 mg, 30-minutes infusion, intravenously once on Days -1 (before allo-HSCT on Day 1), and Days 13 and 42 (after allo-HSCT on Day 1).
Infections and infestations Bronchitis	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Cellulitis	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Cytomegalovirus colitis	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Influenza	33.3% 1/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Mucosal infection	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Pneumonia	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.5% 2/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.5% 2/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Blood and lymphatic system disorders Thrombotic thrombocytopenic purpura	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Vascular disorders Hypotension	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.5% 2/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Vascular disorders Embolism	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Diarrhoea	33.3% 1/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.5% 2/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Nausea	33.3% 1/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.5% 2/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Vomiting	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia recurrent	33.3% 1/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) T-cell type acute leukaemia	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Renal and urinary disorders Acute kidney injury	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.5% 2/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Pyrexia	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.5% 2/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Transaminases increased	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Weight decreased	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Immune system disorders Graft versus host disease	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Seizure	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Other adverse events

Measure	Cohort 1: Vedolizumab 75 mg n=3 participants at risk Vedolizumab 75 mg, 30-minutes infusion, intravenously, once on Day -1 (before allo-HSCT on Day 1), and Days 13 and 42 (after allo-HSCT on Day 1).	Cohort 2: Vedolizumab 300 mg n=21 participants at risk Vedolizumab 300 mg, 30-minutes infusion, intravenously once on Days -1 (before allo-HSCT on Day 1), and Days 13 and 42 (after allo-HSCT on Day 1).
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 3/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.5% 2/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Axillary mass	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Neck mass	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Blood and lymphatic system disorders Anaemia	66.7% 2/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	71.4% 15/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	19.0% 4/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Blood and lymphatic system disorders Neutropenia	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	19.0% 4/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	19.0% 4/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Cardiac disorders Tachycardia	33.3% 1/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	23.8% 5/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Cardiac disorders Sinus bradycardia	33.3% 1/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Cardiac disorders Cardiac failure	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Cardiac disorders Palpitations	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Cardiac disorders Pericardial effusion	33.3% 1/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Endocrine disorders Adrenal insufficiency	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Eye disorders Dry eye	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Eye disorders Vision blurred	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Diarrhoea	66.7% 2/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	61.9% 13/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Nausea	33.3% 1/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	57.1% 12/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Stomatitis	100.0% 3/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	47.6% 10/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Vomiting	66.7% 2/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	28.6% 6/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Constipation	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	28.6% 6/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	19.0% 4/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Dry mouth	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	19.0% 4/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 3/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Dyspepsia	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 3/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Abdominal distension	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.5% 2/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Anal incontinence	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.5% 2/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.5% 2/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Oesophagitis	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.5% 2/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Proctalgia	33.3% 1/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Anorectal ulcer	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Duodenal ulcer	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Gastritis	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Oral disorder	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Oral dysaesthesia	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Fatigue	100.0% 3/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	57.1% 12/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Pyrexia	66.7% 2/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	52.4% 11/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Oedema peripheral	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	23.8% 5/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Oedema	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	19.0% 4/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Chills	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 3/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Non-cardiac chest pain	33.3% 1/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Chest discomfort	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Infusion site extravasation	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Localised oedema	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Mucosal inflammation	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Pain	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Immune system disorders Acute graft versus host disease in skin	33.3% 1/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Immune system disorders Chronic graft versus host disease	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Immune system disorders Chronic graft versus host disease in skin	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Immune system disorders Engraftment syndrome	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Immune system disorders Hypogammaglobulinaemia	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Cytomegalovirus infection	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	19.0% 4/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Clostridium difficile infection	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 3/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Candida infection	33.3% 1/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Clostridium difficile colitis	33.3% 1/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Cytomegalovirus viraemia	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.5% 2/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Upper respiratory tract infection	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.5% 2/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Urinary tract infection	33.3% 1/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Bacteraemia	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Bronchitis	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Corona virus infection	33.3% 1/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Enterobacter infection	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Escherichia bacteraemia	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Folliculitis	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Fungal skin infection	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Human herpesvirus 6 infection	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Nail infection	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Oral candidiasis	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Pneumonia	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Pseudomonal bacteraemia	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Pulmonary mycosis	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Rhinitis	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Rhinovirus infection	33.3% 1/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Sinusitis	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Skin candida	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Streptococcal infection	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Vulvitis	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Injury, poisoning and procedural complications Allergic transfusion reaction	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Injury, poisoning and procedural complications Contusion	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Injury, poisoning and procedural complications Transfusion reaction	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Platelet count decreased	66.7% 2/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	71.4% 15/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Neutrophil count decreased	33.3% 1/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	47.6% 10/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations White blood cell count decreased	66.7% 2/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 7/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Alanine aminotransferase increased	100.0% 3/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	19.0% 4/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Aspartate aminotransferase increased	66.7% 2/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	23.8% 5/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Blood alkaline phosphatase increased	33.3% 1/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	28.6% 6/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Blood creatinine increased	33.3% 1/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	28.6% 6/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Lymphocyte count decreased	33.3% 1/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	28.6% 6/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Blood bilirubin increased	33.3% 1/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	19.0% 4/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Haemoglobin decreased	33.3% 1/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 3/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Weight decreased	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	19.0% 4/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Hepatic enzyme increased	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.5% 2/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Bacterial test positive	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Blood sodium decreased	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Clostridium test positive	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Ejection fraction decreased	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Enterococcus test positive	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Urine output decreased	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Weight increased	33.3% 1/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hypomagnesaemia	100.0% 3/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	81.0% 17/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hypocalcaemia	33.3% 1/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 7/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 7/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hyperglycaemia	33.3% 1/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	28.6% 6/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 7/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hypokalaemia	33.3% 1/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	23.8% 5/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	19.0% 4/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	19.0% 4/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hyperkalaemia	33.3% 1/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.5% 2/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hyperuricaemia	33.3% 1/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Gout	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hypermagnesaemia	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hyperphosphataemia	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Muscular weakness	33.3% 1/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	19.0% 4/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	33.3% 1/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	19.0% 4/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Myalgia	33.3% 1/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 3/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	19.0% 4/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Osteoporosis	33.3% 1/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Headache	33.3% 1/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	42.9% 9/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Dysgeusia	33.3% 1/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	19.0% 4/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Neuropathy peripheral	33.3% 1/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 3/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Tremor	33.3% 1/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 3/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Dizziness	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 3/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Cognitive disorder	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Depressed level of consciousness	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Memory impairment	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Presyncope	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Somnolence	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Syncope	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Product Issues Product contamination microbial	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Psychiatric disorders Insomnia	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 3/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Psychiatric disorders Depression	33.3% 1/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Psychiatric disorders Agitation	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Psychiatric disorders Delirium	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Psychiatric disorders Irritability	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Psychiatric disorders Restlessness	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Renal and urinary disorders Acute kidney injury	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.5% 2/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Renal and urinary disorders Dysuria	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.5% 2/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Renal and urinary disorders Haematuria	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.5% 2/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Renal and urinary disorders Cystitis noninfective	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Renal and urinary disorders Nephrolithiasis	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Renal and urinary disorders Pollakiuria	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Renal and urinary disorders Urinary incontinence	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Reproductive system and breast disorders Oedema genital	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Reproductive system and breast disorders Scrotal erythema	33.3% 1/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	33.3% 1/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	23.8% 5/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Cough	33.3% 1/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 3/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Epistaxis	66.7% 2/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.5% 2/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 3/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.5% 2/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	33.3% 1/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.5% 2/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Idiopathic pneumonia syndrome	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	33.3% 1/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Rash maculo-papular	33.3% 1/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	28.6% 6/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Rash	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	28.6% 6/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 3/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.5% 2/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.5% 2/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	33.3% 1/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Actinic keratosis	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Blister	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Hyperkeratosis	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Swelling face	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Transient acantholytic dermatosis	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Vascular disorders Hypertension	66.7% 2/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	28.6% 6/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Vascular disorders Hypotension	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 3/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Vascular disorders Deep vein thrombosis	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Vascular disorders Haematoma	0.00% 0/3 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 1/21 • TEAEs are adverse events that started after the first dose of study drug and no more than Week 18 after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Additional Information

Medical Director

Takeda

Phone: +1-877-825-3327

Email: trialdisclosures@takeda.com

Results disclosure agreements

• Principal investigator is a sponsor employee Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
• Publication restrictions are in place

Restriction type: OTHER