Trial Outcomes & Findings for Vadastuximab Talirine (SGN-CD33A; 33A) Combined With Azacitidine or Decitabine in Older Patients With Newly Diagnosed Acute Myeloid Leukemia (NCT NCT02785900)

NCT ID: NCT02785900

Last Updated: 2018-12-12

Results Overview

Time from randomization to death due to any cause

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 240 participants
• Primary outcome timeframe: Up to 1.5 years
• Results posted on: 2018-12-12

Participant Flow

Participant milestones

Measure	33A + HMA 33A plus azacitidine or decitabine 33A: 33A, 10 mcg/kg, every 4 weeks via intravenous (IV) push azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks	Placebo + HMA placebo plus azacitidine or decitabine placebo: Volume equivalent to 10 mcg/kg, every 4 weeks via IV push azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks
Overall Study STARTED	117	123
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	117	123

Reasons for withdrawal

Measure	33A + HMA 33A plus azacitidine or decitabine 33A: 33A, 10 mcg/kg, every 4 weeks via intravenous (IV) push azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks	Placebo + HMA placebo plus azacitidine or decitabine placebo: Volume equivalent to 10 mcg/kg, every 4 weeks via IV push azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks
Overall Study Study Termination by Sponsor	64	81
Overall Study Death	46	32
Overall Study Withdrawal by Subject	4	8
Overall Study Physician Decision	3	2

Baseline Characteristics

Vadastuximab Talirine (SGN-CD33A; 33A) Combined With Azacitidine or Decitabine in Older Patients With Newly Diagnosed Acute Myeloid Leukemia

Baseline characteristics by cohort

Measure	33A + HMA n=117 Participants 33A plus azacitidine or decitabine 33A: 33A, 10 mcg/kg, every 4 weeks via intravenous (IV) push azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks	Placebo + HMA n=123 Participants placebo plus azacitidine or decitabine placebo: Volume equivalent to 10 mcg/kg, every 4 weeks via IV push azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks	Total n=240 Participants Total of all reporting groups
Age, Continuous	75.0 years n=5 Participants	75.0 years n=7 Participants	75.0 years n=5 Participants
Age, Customized Age Group · >65 years	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Age, Customized Age Group · 65 - 74 years	55 Participants n=5 Participants	55 Participants n=7 Participants	110 Participants n=5 Participants
Age, Customized Age Group · 75 - 79 years	33 Participants n=5 Participants	41 Participants n=7 Participants	74 Participants n=5 Participants
Age, Customized Age Group · >= 80 years	26 Participants n=5 Participants	24 Participants n=7 Participants	50 Participants n=5 Participants
Sex: Female, Male Female	69 Participants n=5 Participants	67 Participants n=7 Participants	136 Participants n=5 Participants
Sex: Female, Male Male	48 Participants n=5 Participants	56 Participants n=7 Participants	104 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	98 Participants n=5 Participants	111 Participants n=7 Participants	209 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	16 Participants n=5 Participants	10 Participants n=7 Participants	26 Participants n=5 Participants
Race/Ethnicity, Customized Race · American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	12 Participants n=5 Participants	16 Participants n=7 Participants	28 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black or African American	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	85 Participants n=5 Participants	94 Participants n=7 Participants	179 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Race · Not Reportable	13 Participants n=5 Participants	10 Participants n=7 Participants	23 Participants n=5 Participants
Race/Ethnicity, Customized Race · Unknown	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment Hungary	5 participants n=5 Participants	6 participants n=7 Participants	11 participants n=5 Participants
Region of Enrollment United States	49 participants n=5 Participants	45 participants n=7 Participants	94 participants n=5 Participants
Region of Enrollment Czechia	3 participants n=5 Participants	6 participants n=7 Participants	9 participants n=5 Participants
Region of Enrollment United Kingdom	5 participants n=5 Participants	3 participants n=7 Participants	8 participants n=5 Participants
Region of Enrollment Spain	5 participants n=5 Participants	6 participants n=7 Participants	11 participants n=5 Participants
Region of Enrollment South Korea	6 participants n=5 Participants	7 participants n=7 Participants	13 participants n=5 Participants
Region of Enrollment Austria	3 participants n=5 Participants	0 participants n=7 Participants	3 participants n=5 Participants
Region of Enrollment Belgium	4 participants n=5 Participants	8 participants n=7 Participants	12 participants n=5 Participants
Region of Enrollment Taiwan	5 participants n=5 Participants	5 participants n=7 Participants	10 participants n=5 Participants
Region of Enrollment Italy	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants
Region of Enrollment Israel	5 participants n=5 Participants	7 participants n=7 Participants	12 participants n=5 Participants
Region of Enrollment France	13 participants n=5 Participants	10 participants n=7 Participants	23 participants n=5 Participants
Region of Enrollment Australia	10 participants n=5 Participants	11 participants n=7 Participants	21 participants n=5 Participants
Region of Enrollment Germany	2 participants n=5 Participants	6 participants n=7 Participants	8 participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status Grade 0: Normal activity	23 Participants n=5 Participants	23 Participants n=7 Participants	46 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status Grade 1: Symptoms but ambulatory	78 Participants n=5 Participants	80 Participants n=7 Participants	158 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status Grade 2: In bed less than 50% of the time	16 Participants n=5 Participants	20 Participants n=7 Participants	36 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 1.5 years

Population: Intent-to-treat analysis set

Time from randomization to death due to any cause

Outcome measures

Measure	33A + HMA n=117 Participants 33A plus azacitidine or decitabine 33A: 33A, 10 mcg/kg, every 4 weeks via intravenous (IV) push azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks	Placebo + HMA n=123 Participants placebo plus azacitidine or decitabine placebo: Volume equivalent to 10 mcg/kg, every 4 weeks via IV push azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks
Overall Survival	5.1 months Interval 2.3 to 9.9	NA months Interval 4.0 to Insufficient number of participants with events

PRIMARY outcome

Timeframe: Up to 1.5 years

Population: Intent-to-treat analysis set

Number of patients who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi) according to the modified response criteria for acute myeloid leukemia (AML) per Cheson 2003.

Outcome measures

Measure	33A + HMA n=117 Participants 33A plus azacitidine or decitabine 33A: 33A, 10 mcg/kg, every 4 weeks via intravenous (IV) push azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks	Placebo + HMA n=123 Participants placebo plus azacitidine or decitabine placebo: Volume equivalent to 10 mcg/kg, every 4 weeks via IV push azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks
Composite Complete Remission (CRc) Rate	30 participants Interval 18.0 to 34.5	26 participants Interval 14.3 to 29.4

SECONDARY outcome

Timeframe: Up to 1.5 years

Population: Intent-to-treat analysis set

Number of patients who achieve both remission (CR or CRi) and MRD-negative status

Outcome measures

Measure	33A + HMA n=117 Participants 33A plus azacitidine or decitabine 33A: 33A, 10 mcg/kg, every 4 weeks via intravenous (IV) push azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks	Placebo + HMA n=123 Participants placebo plus azacitidine or decitabine placebo: Volume equivalent to 10 mcg/kg, every 4 weeks via IV push azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks
Minimal Residual Disease (MRD)-Negative Composite Complete Remission Rate MRD-negative CRc rate	18 participants Interval 9.4 to 23.2	10 participants Interval 4.0 to 14.4
Minimal Residual Disease (MRD)-Negative Composite Complete Remission Rate MRD-negative CR rate	8 participants Interval 3.0 to 13.0	5 participants Interval 1.3 to 9.2
Minimal Residual Disease (MRD)-Negative Composite Complete Remission Rate MRD-negative CRi rate	10 participants Interval 4.2 to 15.2	5 participants Interval 1.3 to 9.2

SECONDARY outcome

Timeframe: Up to approximately 9.5 months

Population: Patients who achieved complete remission (CR) or CR with incomplete hematologic recovery (CRi).

Duration of remission is calculated from the first documentation of CR or CRi to the first documentation of disease relapse or death, whichever comes first. Patients who are in remission at the time of analysis cutoff are censored at the date of last response assessment. Patients who started another anticancer therapy before relapse or death are censored at the date of last response assessment prior to start of new therapy.

Outcome measures

Measure	33A + HMA n=30 Participants 33A plus azacitidine or decitabine 33A: 33A, 10 mcg/kg, every 4 weeks via intravenous (IV) push azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks	Placebo + HMA n=26 Participants placebo plus azacitidine or decitabine placebo: Volume equivalent to 10 mcg/kg, every 4 weeks via IV push azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks
Duration of Remission	5.1 months Interval 0.03 to 6.21	7.5 months Interval 0.03 to 9.49

SECONDARY outcome

Timeframe: Up to approximately 11.24 months

Population: Intent-to-treat analysis set

Event-free survival is calculated from the time of randomization to the first documentation of progression, relapse, or death, whichever comes first. Patients who do not have event (progression, relapse, or death) prior to analysis cutoff date are censored at the date of last response assessment. Patients who started another anticancer therapy before progression, relapse, or death are censored at the date of last response assessment prior to the start of new therapy. Patients who do not have response assessment post-baseline are censored at the date of randomization.

Outcome measures

Measure	33A + HMA n=117 Participants 33A plus azacitidine or decitabine 33A: 33A, 10 mcg/kg, every 4 weeks via intravenous (IV) push azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks	Placebo + HMA n=123 Participants placebo plus azacitidine or decitabine placebo: Volume equivalent to 10 mcg/kg, every 4 weeks via IV push azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks
Event-free Survival	4.2 months Interval 3.5 to 5.1	6.7 months Interval 4.5 to 9.5

SECONDARY outcome

Timeframe: Up to approximately 9.49 months

Population: Patients who achieved CR/CRi

Leukemia-free survival is calculated from the first documentation of blast clearance (CR, CRi, mLFS) to the first documentation of disease relapse or death, whichever comes first. Patients who are in remission at the time of analysis cutoff are censored at the date of last response assessment. Patients who started another anticancer therapy before relapse or death are censored at the date of last response assessment prior to start of new therapy.

Outcome measures

Measure	33A + HMA n=30 Participants 33A plus azacitidine or decitabine 33A: 33A, 10 mcg/kg, every 4 weeks via intravenous (IV) push azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks	Placebo + HMA n=26 Participants placebo plus azacitidine or decitabine placebo: Volume equivalent to 10 mcg/kg, every 4 weeks via IV push azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks
Leukemia-free Survival	5.1 months Interval 0.03 to 8.31	7.5 months Interval 0.03 to 9.49

SECONDARY outcome

Timeframe: Up to 1.5 years

Population: Safety analysis set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.

Treatment-emergent adverse events (TEAEs) are presented and defined as newly occurring (not present at baseline) or worsening after first dose of investigational product. SAE = serious adverse event. "Study treatment" in this data set refers to blinded study treatment.

Outcome measures

Measure	33A + HMA n=111 Participants 33A plus azacitidine or decitabine 33A: 33A, 10 mcg/kg, every 4 weeks via intravenous (IV) push azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks	Placebo + HMA n=128 Participants placebo plus azacitidine or decitabine placebo: Volume equivalent to 10 mcg/kg, every 4 weeks via IV push azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks
Type, Incidence, Severity, Seriousness, and Relatedness of Adverse Events Patient with any TEAE	111 Participants	125 Participants
Type, Incidence, Severity, Seriousness, and Relatedness of Adverse Events Patients with any AE related to study treatment	83 Participants	59 Participants
Type, Incidence, Severity, Seriousness, and Relatedness of Adverse Events Patients with any SAE	92 Participants	89 Participants
Type, Incidence, Severity, Seriousness, and Relatedness of Adverse Events Patients with any SAE related to study treatment	51 Participants	20 Participants
Type, Incidence, Severity, Seriousness, and Relatedness of Adverse Events Patients with Grade 3 or Higher AE	103 Participants	112 Participants

SECONDARY outcome

Timeframe: Up to 1.5 years

Population: Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.

Participants who experienced a laboratory grade increase to Grade 3 or higher (per National Cancer Institute's Common Terminology Criteria for Adverse Events [NCI CTCAE], v4.03)

Outcome measures

Measure	33A + HMA n=111 Participants 33A plus azacitidine or decitabine 33A: 33A, 10 mcg/kg, every 4 weeks via intravenous (IV) push azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks	Placebo + HMA n=128 Participants placebo plus azacitidine or decitabine placebo: Volume equivalent to 10 mcg/kg, every 4 weeks via IV push azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks
Incidence of Grade 3 or Higher Laboratory Abnormalities Alanine Aminotransferase (IU/L) - High	0 Participants	2 Participants
Incidence of Grade 3 or Higher Laboratory Abnormalities Albumin (g/dL) - Low	2 Participants	4 Participants
Incidence of Grade 3 or Higher Laboratory Abnormalities Alkaline Phosphatase (IU/L) - High	0 Participants	2 Participants
Incidence of Grade 3 or Higher Laboratory Abnormalities Amylase (IU/L) - High	1 Participants	0 Participants
Incidence of Grade 3 or Higher Laboratory Abnormalities Aspartate Aminotransferase (IU/L) - High	1 Participants	2 Participants
Incidence of Grade 3 or Higher Laboratory Abnormalities Bilirubin (mg/dL) - High	1 Participants	1 Participants
Incidence of Grade 3 or Higher Laboratory Abnormalities Calcium (mg/dL) - Low	8 Participants	3 Participants
Incidence of Grade 3 or Higher Laboratory Abnormalities Creatinine (mg/dL) - High	0 Participants	1 Participants
Incidence of Grade 3 or Higher Laboratory Abnormalities Glucose (mg/dL) - High	12 Participants	9 Participants
Incidence of Grade 3 or Higher Laboratory Abnormalities Magnesium (mg/dL) - High	2 Participants	0 Participants
Incidence of Grade 3 or Higher Laboratory Abnormalities Phosphate (mg/dL) - Low	17 Participants	9 Participants
Incidence of Grade 3 or Higher Laboratory Abnormalities Potassium (mEq/L) - High	1 Participants	0 Participants
Incidence of Grade 3 or Higher Laboratory Abnormalities Potassium (mEq/L) - Low	5 Participants	14 Participants
Incidence of Grade 3 or Higher Laboratory Abnormalities Sodium (mEq/L) - Low	13 Participants	12 Participants
Incidence of Grade 3 or Higher Laboratory Abnormalities Triacylglycerol Lipase (IU/L) - High	10 Participants	4 Participants
Incidence of Grade 3 or Higher Laboratory Abnormalities Urate (mg/dL) - High	4 Participants	7 Participants
Incidence of Grade 3 or Higher Laboratory Abnormalities Hemoglobin (g/dL) - Low	59 Participants	66 Participants
Incidence of Grade 3 or Higher Laboratory Abnormalities Leukocytes (x10^3/uL) - High	0 Participants	3 Participants
Incidence of Grade 3 or Higher Laboratory Abnormalities Leukocytes (x10^3/uL) - Low	86 Participants	70 Participants
Incidence of Grade 3 or Higher Laboratory Abnormalities Lymphocytes (x10^3/uL) - High	1 Participants	4 Participants
Incidence of Grade 3 or Higher Laboratory Abnormalities Lymphocytes (x10^3/uL) - Low	51 Participants	29 Participants
Incidence of Grade 3 or Higher Laboratory Abnormalities Neutrophils (x10^3/uL) - Low	63 Participants	43 Participants
Incidence of Grade 3 or Higher Laboratory Abnormalities Platelets (x10^3/uL) - Low	77 Participants	75 Participants

SECONDARY outcome

Timeframe: Up to 1.5 years

Population: Intent-to-Treat Analysis Set - Patients who Achieved CR/CRi.

Time to CR or CRi is the time from randomization to the first documentation of CR/CRi

Outcome measures

Measure	33A + HMA n=30 Participants 33A plus azacitidine or decitabine 33A: 33A, 10 mcg/kg, every 4 weeks via intravenous (IV) push azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks	Placebo + HMA n=26 Participants placebo plus azacitidine or decitabine placebo: Volume equivalent to 10 mcg/kg, every 4 weeks via IV push azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks
Time to Complete Remission	9.3 weeks Interval 5.0 to 22.0	9.4 weeks Interval 7.0 to 26.0

SECONDARY outcome

Timeframe: Up to 60 days

Population: Intent-to-Treat Analysis Set

30- and 60-day survival from date of randomization. Estimated using Kaplan-Meier method.

Outcome measures

Measure	33A + HMA n=117 Participants 33A plus azacitidine or decitabine 33A: 33A, 10 mcg/kg, every 4 weeks via intravenous (IV) push azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks	Placebo + HMA n=123 Participants placebo plus azacitidine or decitabine placebo: Volume equivalent to 10 mcg/kg, every 4 weeks via IV push azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks
Mortality Rates at Day 30 and Day 60 30-day Mortality Rate	11 percentage of participants Interval 7.0 to 18.0	6 percentage of participants Interval 3.0 to 12.0
Mortality Rates at Day 30 and Day 60 60-day Mortality Rate	23 percentage of participants Interval 16.0 to 32.0	13 percentage of participants Interval 8.0 to 20.0

Adverse Events

33A + HMA

Serious events: 92 serious events

Other events: 105 other events

Deaths: 43 deaths

Placebo + HMA

Serious events: 89 serious events

Other events: 123 other events

Deaths: 34 deaths

Serious adverse events

Measure	33A + HMA n=111 participants at risk 33A plus azacitidine or decitabine 33A: 33A, 10 mcg/kg, every 4 weeks via intravenous (IV) push azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks	Placebo + HMA n=128 participants at risk placebo plus azacitidine or decitabine placebo: Volume equivalent to 10 mcg/kg, every 4 weeks via IV push azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks
Infections and infestations Pneumonia	19.8% 22/111 • Number of events 24 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	11.7% 15/128 • Number of events 16 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Infections and infestations Sepsis	12.6% 14/111 • Number of events 15 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	5.5% 7/128 • Number of events 10 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Infections and infestations Cellulitis	5.4% 6/111 • Number of events 6 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	6.2% 8/128 • Number of events 8 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Infections and infestations Lung infection	8.1% 9/111 • Number of events 10 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	2.3% 3/128 • Number of events 3 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Infections and infestations Septic shock	5.4% 6/111 • Number of events 6 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Infections and infestations Urinary tract infection	1.8% 2/111 • Number of events 2 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	3.1% 4/128 • Number of events 4 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Infections and infestations Diverticulitis	1.8% 2/111 • Number of events 2 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	2.3% 3/128 • Number of events 3 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Infections and infestations Bronchitis	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	2.3% 3/128 • Number of events 3 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Infections and infestations Bacteraemia	1.8% 2/111 • Number of events 2 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Infections and infestations Klebsiella sepsis	2.7% 3/111 • Number of events 3 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Infections and infestations Staphylococcal infection	1.8% 2/111 • Number of events 2 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Infections and infestations Abdominal infection	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Infections and infestations Device related infection	1.8% 2/111 • Number of events 2 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Infections and infestations Infection	1.8% 2/111 • Number of events 2 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Infections and infestations Influenza	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Infections and infestations Lower respiratory tract infection	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Infections and infestations Neutropenic sepsis	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Infections and infestations Pseudomonal sepsis	1.8% 2/111 • Number of events 2 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Infections and infestations Streptococcal sepsis	1.8% 2/111 • Number of events 2 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Infections and infestations Acinetobacter bacteraemia	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Infections and infestations Anal abscess	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Infections and infestations Bronchopulmonary aspergillosis	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Infections and infestations Catheter site cellulitis	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Infections and infestations Cellulitis staphylococcal	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Infections and infestations Clostridium difficile colitis	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Infections and infestations Clostridium difficile infection	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Infections and infestations Diarrhoea infectious	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Infections and infestations Enterobacter bacteraemia	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Infections and infestations Enterococcal bacteraemia	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Infections and infestations Enterococcal infection	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Infections and infestations Enterococcal sepsis	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Infections and infestations Escherichia sepsis	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Infections and infestations Necrotising fasciitis	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Infections and infestations Parotitis	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Infections and infestations Pharyngitis	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Infections and infestations Pilonidal cyst	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Infections and infestations Pneumonia fungal	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Infections and infestations Pneumonia influenzal	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Infections and infestations Pneumonia respiratory syncytial viral	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Infections and infestations Postoperative wound infection	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Infections and infestations Pseudomonal bacteraemia	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Infections and infestations Pseudomonas infection	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Infections and infestations Sialoadenitis	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Infections and infestations Sinusitis	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Infections and infestations Skin infection	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Infections and infestations Soft tissue infection	0.90% 1/111 • Number of events 2 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Infections and infestations Staphylococcal sepsis	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Infections and infestations Subcutaneous abscess	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Infections and infestations Tonsillitis	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Infections and infestations Tooth abscess	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Infections and infestations Upper respiratory tract infection	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Infections and infestations Urinary tract infection bacterial	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Blood and lymphatic system disorders Febrile neutropenia	35.1% 39/111 • Number of events 55 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	24.2% 31/128 • Number of events 39 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Blood and lymphatic system disorders Thrombocytopenia	5.4% 6/111 • Number of events 7 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	1.6% 2/128 • Number of events 2 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Blood and lymphatic system disorders Anaemia	4.5% 5/111 • Number of events 6 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	1.6% 2/128 • Number of events 2 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Blood and lymphatic system disorders Neutropenia	4.5% 5/111 • Number of events 6 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Blood and lymphatic system disorders Febrile bone marrow aplasia	2.7% 3/111 • Number of events 3 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Blood and lymphatic system disorders Leukocytosis	1.8% 2/111 • Number of events 3 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Blood and lymphatic system disorders Pancytopenia	1.8% 2/111 • Number of events 2 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Blood and lymphatic system disorders Bone marrow failure	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Blood and lymphatic system disorders Leukopenia	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
General disorders Pyrexia	7.2% 8/111 • Number of events 8 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	6.2% 8/128 • Number of events 8 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
General disorders General physical health deterioration	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	1.6% 2/128 • Number of events 2 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
General disorders Fatigue	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	1.6% 2/128 • Number of events 2 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
General disorders Multiple organ dysfunction syndrome	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	1.6% 2/128 • Number of events 2 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
General disorders Oedema peripheral	1.8% 2/111 • Number of events 2 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
General disorders Catheter site haemorrhage	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
General disorders Chest pain	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
General disorders Extravasation	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
General disorders Facial pain	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
General disorders Mucosal inflammation	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
General disorders Sudden death	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Gastrointestinal disorders Diarrhoea	2.7% 3/111 • Number of events 3 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	2.3% 3/128 • Number of events 4 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Gastrointestinal disorders Neutropenic colitis	1.8% 2/111 • Number of events 2 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Gastrointestinal disorders Rectal haemorrhage	1.8% 2/111 • Number of events 2 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Gastrointestinal disorders Constipation	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Gastrointestinal disorders Oesophagitis	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	1.6% 2/128 • Number of events 2 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Gastrointestinal disorders Abdominal pain	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Gastrointestinal disorders Anal fistula	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Gastrointestinal disorders Enterocolitis	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Gastrointestinal disorders Gastritis erosive	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Gastrointestinal disorders Gastrointestinal angiodysplasia	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Gastrointestinal disorders Haemorrhoids	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Gastrointestinal disorders Irritable bowel syndrome	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Gastrointestinal disorders Large intestinal obstruction	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Gastrointestinal disorders Melaena	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Gastrointestinal disorders Oesophageal obstruction	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Gastrointestinal disorders Palatal oedema	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Gastrointestinal disorders Proctitis	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Gastrointestinal disorders Stomatitis	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Gastrointestinal disorders Vomiting	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Cardiac disorders Atrial fibrillation	1.8% 2/111 • Number of events 2 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	1.6% 2/128 • Number of events 5 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Cardiac disorders Cardiac failure	1.8% 2/111 • Number of events 2 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	1.6% 2/128 • Number of events 2 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Cardiac disorders Cardiac failure congestive	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	1.6% 2/128 • Number of events 2 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Cardiac disorders Cardiac arrest	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Cardiac disorders Acute coronary syndrome	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Cardiac disorders Acute myocardial infarction	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Cardiac disorders Angina unstable	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Cardiac disorders Arrhythmia supraventricular	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Cardiac disorders Atrial flutter	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Cardiac disorders Atrioventricular block complete	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Cardiac disorders Cardiac failure acute	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Cardiac disorders Cardiopulmonary failure	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Cardiac disorders Myocardial infarction	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Cardiac disorders Myocardial ischaemia	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Cardiac disorders Myocarditis	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Cardiac disorders Pericardial effusion	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Cardiac disorders Supraventricular tachycardia	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Cardiac disorders Ventricular arrhythmia	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Respiratory, thoracic and mediastinal disorders Respiratory failure	2.7% 3/111 • Number of events 3 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	1.6% 2/128 • Number of events 2 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Respiratory, thoracic and mediastinal disorders Epistaxis	2.7% 3/111 • Number of events 3 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	1.6% 2/128 • Number of events 2 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 2 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Vascular disorders Hypotension	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	1.6% 2/128 • Number of events 2 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Vascular disorders Deep vein thrombosis	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Vascular disorders Embolism	1.8% 2/111 • Number of events 2 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Vascular disorders Haematoma	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Vascular disorders Haemorrhage	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Vascular disorders Hypertension	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Vascular disorders Thrombophlebitis	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Vascular disorders Thrombophlebitis superficial	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Metabolism and nutrition disorders Hypokalaemia	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Metabolism and nutrition disorders Tumour lysis syndrome	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	1.6% 2/128 • Number of events 2 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Metabolism and nutrition disorders Dehydration	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Metabolism and nutrition disorders Failure to thrive	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Metabolism and nutrition disorders Fluid overload	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Metabolism and nutrition disorders Hypoglycaemia	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Metabolism and nutrition disorders Lactic acidosis	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Metabolism and nutrition disorders Malnutrition	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Investigations Blood culture positive	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Investigations Ejection fraction decreased	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Investigations Alanine aminotransferase increased	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Investigations Aspartate aminotransferase increased	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Investigations Blood alkaline phosphatase increased	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Investigations Blood creatinine increased	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Investigations C-reactive protein increased	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Investigations General physical condition abnormal	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Renal and urinary disorders Acute kidney injury	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	3.1% 4/128 • Number of events 4 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Renal and urinary disorders Urinary retention	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Renal and urinary disorders Renal failure	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Renal and urinary disorders Urinary bladder haemorrhage	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Renal and urinary disorders Urinary tract pain	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Nervous system disorders Seizure	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Nervous system disorders Cerebrovascular accident	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Nervous system disorders Facial paresis	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Nervous system disorders Haemorrhage intracranial	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Nervous system disorders Metabolic encephalopathy	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Nervous system disorders Serotonin syndrome	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Nervous system disorders Somnolence	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	2.3% 3/128 • Number of events 3 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic renal cell carcinoma	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Injury, poisoning and procedural complications Subdural haematoma	1.8% 2/111 • Number of events 2 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Injury, poisoning and procedural complications Fall	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Injury, poisoning and procedural complications Head injury	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 2 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Injury, poisoning and procedural complications Radiation proctitis	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Injury, poisoning and procedural complications Skin injury	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Injury, poisoning and procedural complications Transfusion reaction	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Musculoskeletal and connective tissue disorders Back pain	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Musculoskeletal and connective tissue disorders Flank pain	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Hepatobiliary disorders Cholecystitis	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Hepatobiliary disorders Cholecystitis acute	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Hepatobiliary disorders Hepatic failure	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Hepatobiliary disorders Hepatitis cholestatic	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Hepatobiliary disorders Hyperbilirubinaemia	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Psychiatric disorders Confusional state	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Psychiatric disorders Delirium	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Psychiatric disorders Mental status changes	0.00% 0/111 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Skin and subcutaneous tissue disorders Vasculitic rash	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Social circumstances Blood product transfusion dependent	0.90% 1/111 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.

Other adverse events

Measure	33A + HMA n=111 participants at risk 33A plus azacitidine or decitabine 33A: 33A, 10 mcg/kg, every 4 weeks via intravenous (IV) push azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks	Placebo + HMA n=128 participants at risk placebo plus azacitidine or decitabine placebo: Volume equivalent to 10 mcg/kg, every 4 weeks via IV push azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks
Gastrointestinal disorders Constipation	35.1% 39/111 • Number of events 48 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	42.2% 54/128 • Number of events 64 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Gastrointestinal disorders Nausea	33.3% 37/111 • Number of events 49 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	35.2% 45/128 • Number of events 56 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Gastrointestinal disorders Diarrhoea	30.6% 34/111 • Number of events 47 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	26.6% 34/128 • Number of events 52 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Gastrointestinal disorders Vomiting	13.5% 15/111 • Number of events 25 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	24.2% 31/128 • Number of events 41 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Gastrointestinal disorders Abdominal pain	9.9% 11/111 • Number of events 13 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	9.4% 12/128 • Number of events 15 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Gastrointestinal disorders Mouth ulceration	6.3% 7/111 • Number of events 7 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	7.0% 9/128 • Number of events 9 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Gastrointestinal disorders Stomatitis	7.2% 8/111 • Number of events 10 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	4.7% 6/128 • Number of events 7 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Gastrointestinal disorders Dyspepsia	9.0% 10/111 • Number of events 10 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Gastrointestinal disorders Haemorrhoids	3.6% 4/111 • Number of events 5 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	5.5% 7/128 • Number of events 7 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Blood and lymphatic system disorders Anaemia	44.1% 49/111 • Number of events 78 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	46.1% 59/128 • Number of events 105 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Blood and lymphatic system disorders Thrombocytopenia	35.1% 39/111 • Number of events 73 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	36.7% 47/128 • Number of events 67 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Blood and lymphatic system disorders Neutropenia	17.1% 19/111 • Number of events 35 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	18.8% 24/128 • Number of events 34 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Blood and lymphatic system disorders Febrile neutropenia	22.5% 25/111 • Number of events 29 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	9.4% 12/128 • Number of events 18 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Blood and lymphatic system disorders Leukopenia	11.7% 13/111 • Number of events 23 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	6.2% 8/128 • Number of events 9 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
General disorders Oedema peripheral	29.7% 33/111 • Number of events 38 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	18.0% 23/128 • Number of events 28 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
General disorders Fatigue	22.5% 25/111 • Number of events 27 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	18.8% 24/128 • Number of events 25 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
General disorders Pyrexia	22.5% 25/111 • Number of events 38 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	14.1% 18/128 • Number of events 31 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
General disorders Asthenia	11.7% 13/111 • Number of events 16 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	10.9% 14/128 • Number of events 14 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
General disorders Injection site erythema	9.9% 11/111 • Number of events 18 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	3.1% 4/128 • Number of events 6 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
General disorders Chills	7.2% 8/111 • Number of events 9 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	3.1% 4/128 • Number of events 5 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
General disorders Localised oedema	5.4% 6/111 • Number of events 11 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.00% 0/128 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Metabolism and nutrition disorders Hypokalaemia	25.2% 28/111 • Number of events 43 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	23.4% 30/128 • Number of events 36 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Metabolism and nutrition disorders Decreased appetite	26.1% 29/111 • Number of events 36 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	21.9% 28/128 • Number of events 29 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Metabolism and nutrition disorders Hypomagnesaemia	9.9% 11/111 • Number of events 17 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	10.2% 13/128 • Number of events 16 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Metabolism and nutrition disorders Hyponatraemia	9.0% 10/111 • Number of events 12 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	10.2% 13/128 • Number of events 22 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Metabolism and nutrition disorders Hypoalbuminaemia	8.1% 9/111 • Number of events 10 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	7.8% 10/128 • Number of events 10 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Metabolism and nutrition disorders Hypocalcaemia	9.0% 10/111 • Number of events 11 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	6.2% 8/128 • Number of events 8 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Metabolism and nutrition disorders Hypophosphataemia	7.2% 8/111 • Number of events 10 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	7.0% 9/128 • Number of events 9 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Metabolism and nutrition disorders Fluid overload	2.7% 3/111 • Number of events 3 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	5.5% 7/128 • Number of events 8 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	15.3% 17/111 • Number of events 20 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	21.9% 28/128 • Number of events 31 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Respiratory, thoracic and mediastinal disorders Cough	18.0% 20/111 • Number of events 22 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	15.6% 20/128 • Number of events 25 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Respiratory, thoracic and mediastinal disorders Epistaxis	18.9% 21/111 • Number of events 32 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	8.6% 11/128 • Number of events 12 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	10.8% 12/111 • Number of events 15 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	3.9% 5/128 • Number of events 5 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	5.4% 6/111 • Number of events 7 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	4.7% 6/128 • Number of events 6 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	5.4% 6/111 • Number of events 6 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	3.1% 4/128 • Number of events 5 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	6.3% 7/111 • Number of events 7 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	2.3% 3/128 • Number of events 3 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Investigations Weight decreased	13.5% 15/111 • Number of events 17 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	13.3% 17/128 • Number of events 17 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Investigations Platelet count decreased	10.8% 12/111 • Number of events 19 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	7.8% 10/128 • Number of events 12 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Investigations Blood creatinine increased	8.1% 9/111 • Number of events 10 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	5.5% 7/128 • Number of events 9 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Investigations Neutrophil count decreased	5.4% 6/111 • Number of events 8 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	6.2% 8/128 • Number of events 13 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Investigations White blood cell count decreased	5.4% 6/111 • Number of events 8 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	3.9% 5/128 • Number of events 10 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Investigations Blood bilirubin increased	5.4% 6/111 • Number of events 6 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	0.78% 1/128 • Number of events 1 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Infections and infestations Cellulitis	9.0% 10/111 • Number of events 11 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	7.8% 10/128 • Number of events 10 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Infections and infestations Oral candidiasis	5.4% 6/111 • Number of events 7 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	7.0% 9/128 • Number of events 10 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Infections and infestations Pneumonia	9.0% 10/111 • Number of events 11 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	2.3% 3/128 • Number of events 3 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Infections and infestations Oral herpes	1.8% 2/111 • Number of events 2 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	7.8% 10/128 • Number of events 12 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Infections and infestations Urinary tract infection	3.6% 4/111 • Number of events 4 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	6.2% 8/128 • Number of events 9 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Skin and subcutaneous tissue disorders Rash	9.9% 11/111 • Number of events 15 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	11.7% 15/128 • Number of events 19 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Skin and subcutaneous tissue disorders Pruritus	6.3% 7/111 • Number of events 8 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	10.2% 13/128 • Number of events 13 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Skin and subcutaneous tissue disorders Erythema	2.7% 3/111 • Number of events 4 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	6.2% 8/128 • Number of events 10 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Skin and subcutaneous tissue disorders Purpura	5.4% 6/111 • Number of events 6 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	1.6% 2/128 • Number of events 2 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Psychiatric disorders Insomnia	18.9% 21/111 • Number of events 22 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	9.4% 12/128 • Number of events 13 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Psychiatric disorders Confusional state	6.3% 7/111 • Number of events 9 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	5.5% 7/128 • Number of events 7 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Psychiatric disorders Anxiety	7.2% 8/111 • Number of events 8 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	3.1% 4/128 • Number of events 4 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	9.0% 10/111 • Number of events 10 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	7.8% 10/128 • Number of events 12 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Musculoskeletal and connective tissue disorders Back pain	4.5% 5/111 • Number of events 5 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	7.0% 9/128 • Number of events 10 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	6.3% 7/111 • Number of events 12 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	4.7% 6/128 • Number of events 6 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Musculoskeletal and connective tissue disorders Muscular weakness	5.4% 6/111 • Number of events 6 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	2.3% 3/128 • Number of events 3 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Vascular disorders Hypotension	10.8% 12/111 • Number of events 12 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	7.0% 9/128 • Number of events 11 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Vascular disorders Haematoma	8.1% 9/111 • Number of events 11 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	7.0% 9/128 • Number of events 12 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Vascular disorders Hypertension	6.3% 7/111 • Number of events 7 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	2.3% 3/128 • Number of events 3 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Nervous system disorders Dizziness	5.4% 6/111 • Number of events 6 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	13.3% 17/128 • Number of events 18 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Nervous system disorders Headache	4.5% 5/111 • Number of events 7 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	13.3% 17/128 • Number of events 18 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Nervous system disorders Dysgeusia	6.3% 7/111 • Number of events 7 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	3.9% 5/128 • Number of events 5 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Injury, poisoning and procedural complications Contusion	9.9% 11/111 • Number of events 14 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	5.5% 7/128 • Number of events 11 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Injury, poisoning and procedural complications Fall	9.0% 10/111 • Number of events 13 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	3.9% 5/128 • Number of events 5 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Cardiac disorders Atrial fibrillation	7.2% 8/111 • Number of events 8 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	2.3% 3/128 • Number of events 3 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Cardiac disorders Sinus tachycardia	6.3% 7/111 • Number of events 7 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	2.3% 3/128 • Number of events 3 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Renal and urinary disorders Acute kidney injury	5.4% 6/111 • Number of events 6 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	4.7% 6/128 • Number of events 8 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Renal and urinary disorders Urinary retention	5.4% 6/111 • Number of events 6 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	1.6% 2/128 • Number of events 2 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.
Ear and labyrinth disorders Ear pain	5.4% 6/111 • Number of events 8 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.	1.6% 2/128 • Number of events 3 • Up to 13 months Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug. Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.

Additional Information

Chief Medical Officer

Seattle Genetics, Inc.

Phone: 855-473-2436

Email: medinfo@seagen.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60