Trial Outcomes & Findings for HEPLISAV-B® in Adults With End-Stage Renal Disease (ESRD) Undergoing Hemodialysis (NCT NCT03934736)

Last Updated: 2024-08-09

Results Overview

Proportion of participants with Medically-attended adverse events (MAEs), Serious Adverse Events (SAEs), and immune-mediated Adverse Events of Special Interest (AESIs). MAEs are Adverse events (AEs) for which a subject sought medical attention at a doctor's office, clinic or study site, or emergency room, or was hospitalized. SAEs are AEs that met the definition of Serious per FDA regulations.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

119 participants

Primary outcome timeframe

Week 0 (Visit 1) until Week 68 or early termination

Results posted on

2024-08-09

Participant Flow

Participant milestones

Participant milestones
Measure	HEPLISAV-B A single dose of 0.5 mL HEPLISAV-B® administered intramuscularly in the deltoid muscle at Week 0 (Visit 1), Week 4 (Visit 2), Week 8 (Visit 3), and Week 16 (Visit 4). HEPLISAV-B®: HEPLISAV-B®, a licensed, commercially-available hepatitis B vaccine consisting of the adjuvant cytidine phosphoguanosine (CpG) 1018 combined with the antigen recombinant hepatitis B surface antigen (rHBsAg).
Overall Study STARTED	119
Overall Study COMPLETED	86
Overall Study NOT COMPLETED	33

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

HEPLISAV-B® in Adults With End-Stage Renal Disease (ESRD) Undergoing Hemodialysis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HEPLISAV-B® n=119 Participants A single dose of 0.5 mL HEPLISAV-B® administered intramuscularly in the deltoid muscle at Week 0 (Visit 1), Week 4 (Visit 2), Week 8 (Visit 3), and Week 16 (Visit 4). HEPLISAV-B®: HEPLISAV-B®, a licensed, commercially-available hepatitis B vaccine consisting of the adjuvant cytidine phosphoguanosine (CpG) 1018 combined with the antigen recombinant hepatitis B surface antigen (rHBsAg).
Age, Continuous	61.0 years n=5 Participants
Age, Customized 18-55	47 Participants n=5 Participants
Age, Customized 56+	72 Participants n=5 Participants
Sex: Female, Male Female	47 Participants n=5 Participants
Sex: Female, Male Male	72 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	97 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	61 Participants n=5 Participants
Race (NIH/OMB) White	51 Participants n=5 Participants
Race (NIH/OMB) More than one race	7 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	119 participants n=5 Participants
Weight	89.2 kg n=5 Participants
Height	170.2 cm n=5 Participants
Body Mass Index	30.1 kg/m^2 n=5 Participants
Smoking Status Yes	24 Participants n=5 Participants
Smoking Status No	95 Participants n=5 Participants
Diabetes Mellitus Status Yes	82 Participants n=5 Participants
Diabetes Mellitus Status No	37 Participants n=5 Participants
History of Hypertension Yes	116 Participants n=5 Participants
History of Hypertension No	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 0 (Visit 1) until Week 68 or early termination

Population: Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data

Outcome measures

Outcome measures
Measure	HEPLISAV-B n=119 Participants A single dose of 0.5 mL HEPLISAV-B® administered intramuscularly in the deltoid muscle at Week 0 (Visit 1), Week 4 (Visit 2), Week 8 (Visit 3), and Week 16 (Visit 4). HEPLISAV-B®: HEPLISAV-B®, a licensed, commercially-available hepatitis B vaccine consisting of the adjuvant cytidine phosphoguanosine (CpG) 1018 combined with the antigen recombinant hepatitis B surface antigen (rHBsAg).
Percentage of Subjects Reporting Clinically Significant Adverse Events - Medically-attended Adverse Events, Serious Adverse Events, and Immune-mediated Adverse Events of Special Interest New-onset Immune-mediated Adverse Events	0.8 percentage of participants
Percentage of Subjects Reporting Clinically Significant Adverse Events - Medically-attended Adverse Events, Serious Adverse Events, and Immune-mediated Adverse Events of Special Interest Medically-attended Adverse Events	66.4 percentage of participants
Percentage of Subjects Reporting Clinically Significant Adverse Events - Medically-attended Adverse Events, Serious Adverse Events, and Immune-mediated Adverse Events of Special Interest Serious Adverse Events	48.7 percentage of participants

PRIMARY outcome

Timeframe: Week 20

Population: Per protocol subjects at Week 20

SPR is the percentage of participants who have a seroprotective immune response (antibody level to anti-HBsAg greater than or equal to 10 milli-international unit \[mIU\]/mL) after HEPLISAV-B

Outcome measures

Outcome measures
Measure	HEPLISAV-B n=75 Participants A single dose of 0.5 mL HEPLISAV-B® administered intramuscularly in the deltoid muscle at Week 0 (Visit 1), Week 4 (Visit 2), Week 8 (Visit 3), and Week 16 (Visit 4). HEPLISAV-B®: HEPLISAV-B®, a licensed, commercially-available hepatitis B vaccine consisting of the adjuvant cytidine phosphoguanosine (CpG) 1018 combined with the antigen recombinant hepatitis B surface antigen (rHBsAg).
Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune Response	89.3 percentage of participants Interval 80.1 to 95.3

SECONDARY outcome

Timeframe: Weeks 4, 8, 16, 20

Population: Per protocol subjects at Weeks 4, 8,16, 20

Percentage of subjects with anti-HBs concentration ≥100 mIU/mL.

Outcome measures

Outcome measures
Measure	HEPLISAV-B n=75 Participants A single dose of 0.5 mL HEPLISAV-B® administered intramuscularly in the deltoid muscle at Week 0 (Visit 1), Week 4 (Visit 2), Week 8 (Visit 3), and Week 16 (Visit 4). HEPLISAV-B®: HEPLISAV-B®, a licensed, commercially-available hepatitis B vaccine consisting of the adjuvant cytidine phosphoguanosine (CpG) 1018 combined with the antigen recombinant hepatitis B surface antigen (rHBsAg).
Percentage of Subjects With Anti-HBs Concentration ≥100 mIU/mL Week 4	5.4 percentage of subjects with anti-HBs≥100 Interval 1.5 to 13.3
Percentage of Subjects With Anti-HBs Concentration ≥100 mIU/mL Week 8	33.8 percentage of subjects with anti-HBs≥100 Interval 23.2 to 45.7
Percentage of Subjects With Anti-HBs Concentration ≥100 mIU/mL Week 16	57.3 percentage of subjects with anti-HBs≥100 Interval 45.4 to 68.7
Percentage of Subjects With Anti-HBs Concentration ≥100 mIU/mL Week 20	81.3 percentage of subjects with anti-HBs≥100 Interval 70.7 to 89.4

SECONDARY outcome

Timeframe: Weeks 4, 8, 16, 20

Population: Per protocol subjects at Week 4, 8, 16, 20

Serum Anti-HBsAg Geometric Mean Concentration (GMC).

Outcome measures

Outcome measures
Measure	HEPLISAV-B n=75 Participants A single dose of 0.5 mL HEPLISAV-B® administered intramuscularly in the deltoid muscle at Week 0 (Visit 1), Week 4 (Visit 2), Week 8 (Visit 3), and Week 16 (Visit 4). HEPLISAV-B®: HEPLISAV-B®, a licensed, commercially-available hepatitis B vaccine consisting of the adjuvant cytidine phosphoguanosine (CpG) 1018 combined with the antigen recombinant hepatitis B surface antigen (rHBsAg).
Serum Anti-HBsAg Geometric Mean Concentration (GMC) Week 8	33.5 mIU/mL Interval 17.5 to 64.3
Serum Anti-HBsAg Geometric Mean Concentration (GMC) Week 4	4.4 mIU/mL Interval 3.0 to 6.5
Serum Anti-HBsAg Geometric Mean Concentration (GMC) Week 16	155.3 mIU/mL Interval 81.5 to 296.2
Serum Anti-HBsAg Geometric Mean Concentration (GMC) Week 20	1061.8 mIU/mL Interval 547.2 to 2060.2

SECONDARY outcome

Timeframe: Weeks 4, 8, 16, 20

Population: Per protocol subjects at Weeks 4, 8,16, 20

SPR is the percentage of participants who have a seroprotective immune response (antibody level to anti-HBsAg greater than or equal to 10 milli-international unit \[mIU\]/mL) after HEPLISAV-B

Outcome measures

Outcome measures
Measure	HEPLISAV-B n=75 Participants A single dose of 0.5 mL HEPLISAV-B® administered intramuscularly in the deltoid muscle at Week 0 (Visit 1), Week 4 (Visit 2), Week 8 (Visit 3), and Week 16 (Visit 4). HEPLISAV-B®: HEPLISAV-B®, a licensed, commercially-available hepatitis B vaccine consisting of the adjuvant cytidine phosphoguanosine (CpG) 1018 combined with the antigen recombinant hepatitis B surface antigen (rHBsAg).
Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune Response Week 4	20.3 SPR percent (≥ 10 mIU/mL) Interval 11.8 to 31.2
Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune Response Week 8	56.8 SPR percent (≥ 10 mIU/mL) Interval 44.7 to 68.2
Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune Response Week 16	78.7 SPR percent (≥ 10 mIU/mL) Interval 67.7 to 87.3
Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune Response Week 20	89.3 SPR percent (≥ 10 mIU/mL) Interval 80.1 to 95.3

Adverse Events

HEPLISAV-B

Serious events: 58 serious events

Other events: 0 other events

Deaths: 14 deaths

Serious adverse events

Serious adverse events
Measure	HEPLISAV-B n=119 participants at risk A single dose of 0.5 mL HEPLISAV-B® administered intramuscularly in the deltoid muscle at Week 0 (Visit 1), Week 4 (Visit 2), Week 8 (Visit 3), and Week 16 (Visit 4). HEPLISAV-B®: HEPLISAV-B®, a licensed, commercially-available hepatitis B vaccine consisting of the adjuvant cytidine phosphoguanosine (CpG) 1018 combined with the antigen recombinant hepatitis B surface antigen (rHBsAg).
Blood and lymphatic system disorders Anemia	4.2% 5/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Blood and lymphatic system disorders Haemorrhagic Anaemia	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Blood and lymphatic system disorders Leukocytosis	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Cardiac disorders Acute Left Ventricular Failure	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Cardiac disorders Acute Myocardial Infarction	2.5% 3/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Cardiac disorders Angina Pectoris	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Cardiac disorders Atrial Fibrillation	1.7% 2/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Cardiac disorders Bradycardia	1.7% 2/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Cardiac disorders Cardiac Arrest	1.7% 2/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Cardiac disorders Cardiac Failure	1.7% 2/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Cardiac disorders Cardiac Failure Acute	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Cardiac disorders Cardiac Failure Congestive	1.7% 2/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Cardiac disorders Cardiogenic Shock	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Cardiac disorders Coronary Artery Stenosis	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Cardiac disorders Mitral Valve Incompetence	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Congenital, familial and genetic disorders Sickle Cell Anaemia	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Gastrointestinal disorders Abdominal Pain	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Gastrointestinal disorders Ascites	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Gastrointestinal disorders Colitis	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Gastrointestinal disorders Gastric Antral Vascular Ectasia	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Gastrointestinal disorders Gastric Polyps	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Gastrointestinal disorders Gastrointestinal Haemorrhage	4.2% 5/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Gastrointestinal disorders Haematemesis	1.7% 2/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Gastrointestinal disorders Impaired Gastric Emptying	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Gastrointestinal disorders Lower Gastrointestinal Haemorrhage	2.5% 3/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Gastrointestinal disorders Melaena	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Gastrointestinal disorders Oesophageal Food Impaction	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Gastrointestinal disorders Pancreatitis	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Gastrointestinal disorders Pancreatitis Acute	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Gastrointestinal disorders Pancreatitis Chronic	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Gastrointestinal disorders Rectal Haemorrhage	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Gastrointestinal disorders Small Intestinal Obstruction	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Gastrointestinal disorders Upper Gastrointestinal Haemorrhage	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
General disorders Chest Discomfort	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
General disorders Death	1.7% 2/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
General disorders Gait Disturbance	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
General disorders Non-Cardiac Chest Pain	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
General disorders Pyrexia	1.7% 2/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Hepatobiliary disorders Cholecystitis	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Hepatobiliary disorders Hepatotoxicity	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Infections and infestations Abdominal Abscess	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Infections and infestations Bacteraemia	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Infections and infestations Cellulitis	3.4% 4/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Infections and infestations Clostridium Difficile Colitis	1.7% 2/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Infections and infestations Clostridium Difficile Infection	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Infections and infestations Corona Virus Infection	3.4% 4/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Infections and infestations Diverticulitis	2.5% 3/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Infections and infestations Epididymitis	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Infections and infestations Gangrene	1.7% 2/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Infections and infestations Influenza	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Infections and infestations Localised Infection	1.7% 2/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Infections and infestations Oesophageal Candidiasis	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Infections and infestations Osteomyelitis	1.7% 2/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Infections and infestations Osteomyelitis Chronic	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Infections and infestations Pneumonia	7.6% 9/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Infections and infestations Pneumonia Viral	2.5% 3/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Infections and infestations Pyelonephritis	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Infections and infestations Sepsis	4.2% 5/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Infections and infestations Septic Shock	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Infections and infestations Urinary Tract Infection	1.7% 2/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Infections and infestations Urosepsis	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Injury, poisoning and procedural complications Acetabulum Fracture	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Injury, poisoning and procedural complications Arteriovenous Fistula Site Haemorrhage	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Injury, poisoning and procedural complications Exposure to Household Chemicals	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Injury, poisoning and procedural complications Fall	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Injury, poisoning and procedural complications Intentional Overdose	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Injury, poisoning and procedural complications Post Procedural Haemorrhage	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Injury, poisoning and procedural complications Rib Fracture	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Investigations Anticoagulation Drug Level Above Therapeutic	1.7% 2/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Investigations Blood Culture Positive	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Investigations Coronavirus Test Positive	1.7% 2/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Metabolism and nutrition disorders Acidosis	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Metabolism and nutrition disorders Adult Failure to Thrive	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Metabolism and nutrition disorders Diabetic Ketoacidosis	1.7% 2/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Metabolism and nutrition disorders Electrolyte Imbalance	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Metabolism and nutrition disorders Fluid Overload	3.4% 4/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Metabolism and nutrition disorders Gout	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Metabolism and nutrition disorders Hyperkalaemia	3.4% 4/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Metabolism and nutrition disorders Hypoglycaemia	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Metabolism and nutrition disorders Ketosis	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Metabolism and nutrition disorders Lactic Acidosis	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Metabolism and nutrition disorders Metabolic Acidosis	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Musculoskeletal and connective tissue disorders Flank Pain	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Musculoskeletal and connective tissue disorders Osteoarthritis	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Musculoskeletal and connective tissue disorders Pain in Extremity	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain Neoplasm Malignant	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary Renal Cell Carcinoma	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Nervous system disorders Cerebral Haemorrhage	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Nervous system disorders Metabolic Encephalopathy	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Nervous system disorders Seizure	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Nervous system disorders Syncope	3.4% 4/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Product Issues Device Damage	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Product Issues Device Malfunction	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Renal and urinary disorders Azotaemia	1.7% 2/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Renal and urinary disorders End Stage Renal Disease	1.7% 2/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Respiratory, thoracic and mediastinal disorders Acute Pulmonary Oedema	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	3.4% 4/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Respiratory, thoracic and mediastinal disorders Epistaxis	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Respiratory, thoracic and mediastinal disorders Hypoxia	1.7% 2/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Respiratory, thoracic and mediastinal disorders Pulmonary Haemorrhage	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Respiratory, thoracic and mediastinal disorders Pulmonary Hypertension	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Respiratory, thoracic and mediastinal disorders Pulmonary Oedema	1.7% 2/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Respiratory, thoracic and mediastinal disorders Respiratory Failure	2.5% 3/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Skin and subcutaneous tissue disorders Decubitus Ulcer	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Skin and subcutaneous tissue disorders Hidradenitis	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Skin and subcutaneous tissue disorders Skin Ulcer	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Vascular disorders Aortic Stenosis	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Vascular disorders Aortitis	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Vascular disorders Hypertensive Emergency	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Vascular disorders Hypotension	1.7% 2/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE
Vascular disorders Temporal Arteritis	0.84% 1/119 • The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68). An MAE is an AE for which a subject sought medical attention at a doctor's office, clinic, study site, emergency room, or was hospitalized. In this trial, only MAEs were collected. Medical conditions present at Screening (ie, before informed consent was obtained) or present before the first study treatment (Day 1) are medical history, not MAEs. Any increase in severity or frequency of a medical condition documented as medical history after the first study treatment was recorded as an MAE

Other adverse events

Adverse event data not reported

Additional Information

Robert Janssen, MD, Senior Vice President & Chief Medical Officer

Dynavax Technologies Corporation

Phone: 5106650414

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If no multicenter publication has occurred within 18 months of the completion of this Study, Investigator shall have the right to publish or present independently the results of this Study. Investigator shall provide Dynavax with a copy of any such presentation/publication derived from the Study for review at least 30 days in advance of submission. Except for the Study Data, Dynavax reserves the right to delete any Intellectual Property or other confidential information of Dynavax.
Publication restrictions are in place

Restriction type: OTHER