Trial Outcomes & Findings for Safety and Immunogenicity Study of the Hepatitis B Vaccine, HEPLISAV™, Compared to Engerix-B® Vaccine (NCT NCT02117934)

NCT ID: NCT02117934

Last Updated: 2019-03-20

Results Overview

The percentage 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. Immune-mediated AESIs are AEs that were confirmed to be autoimmune in etiology.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 8374 participants
• Primary outcome timeframe: Week 56
• Results posted on: 2019-03-20

Participant Flow

Participant milestones

Measure	HEPLISAV 0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) HEPLISAV and/or Placebo: Intramuscular (IM) injections at Week 0, Week 4, plus a placebo (saline) injection at Week 24	Engerix-B 1.0 mL Engerix-B Engerix-B: Intramuscular injections at Week 0, Week 4, and Week 24
Overall Study STARTED	5592	2782
Overall Study COMPLETED	5092	2567
Overall Study NOT COMPLETED	500	215

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Immunogenicity Study of the Hepatitis B Vaccine, HEPLISAV™, Compared to Engerix-B® Vaccine

Baseline characteristics by cohort

Measure	HEPLISAV n=5587 Participants 0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) HEPLISAV and/or Placebo: Intramuscular (IM) injections at Week 0, Week 4, plus a placebo (saline) injection at Week 24	Engerix-B n=2781 Participants 1.0 mL Engerix-B Engerix-B: Intramuscular injections at Week 0, Week 4, and Week 24	Total n=8368 Participants Total of all reporting groups
Age, Customized Age ≥ 18 to ≤ 39 years	1132 Participants n=5 Participants	561 Participants n=7 Participants	1693 Participants n=5 Participants
Age, Customized Age ≥ 40 years	4455 Participants n=5 Participants	2220 Participants n=7 Participants	6675 Participants n=5 Participants
Sex: Female, Male Female	2743 Participants n=5 Participants	1390 Participants n=7 Participants	4133 Participants n=5 Participants
Sex: Female, Male Male	2844 Participants n=5 Participants	1391 Participants n=7 Participants	4235 Participants n=5 Participants
Region of Enrollment United States	5587 Participants n=5 Participants	2781 Participants n=7 Participants	8368 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 56

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

The percentage 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. Immune-mediated AESIs are AEs that were confirmed to be autoimmune in etiology.

Outcome measures

Measure	HEPLISAV n=5587 Participants 0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) HEPLISAV and/or Placebo: Intramuscular (IM) injections at Week 0, Week 4, plus a placebo (saline) injection at Week 24	Engerix-B n=2781 Participants 1.0 mL Engerix-B Engerix-B: Intramuscular injections at Week 0, Week 4, and Week 24
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	0.1 percentage of participants	0.04 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	46.0 percentage of participants	46.2 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	6.2 percentage of participants	5.3 percentage of participants

PRIMARY outcome

Timeframe: Week 28

Population: Per-Protocol Diabetes Population:Randomized subjects with type 2 diabetes mellitus (clinical diagnosis of T2DM taking at least oral or non-insulin injectable hypoglycemic agent and/or insulin) who received all study injections, had no major protocol deviations, and had anti-HBs levels obtained within the study visit window at Week 28.

Percentage of subjects with type 2 diabetes mellitus who have a seroprotective immune response (anti-HBs ≥ 10 milli-international unit (mIU)/mL) who receive HEPLISAV compared with subjects who receive Engerix-B

Outcome measures

Measure	HEPLISAV n=640 Participants 0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) HEPLISAV and/or Placebo: Intramuscular (IM) injections at Week 0, Week 4, plus a placebo (saline) injection at Week 24	Engerix-B n=321 Participants 1.0 mL Engerix-B Engerix-B: Intramuscular injections at Week 0, Week 4, and Week 24
Percentage of Subjects With Type 2 Diabetes Mellitus Who Have a Seroprotective Immune Response	90.0 Percentage of participants Interval 87.4 to 92.2	65.1 Percentage of participants Interval 59.6 to 70.3

Adverse Events

HEPLISAV

Serious events: 345 serious events

Other events: 1097 other events

Deaths: 0 deaths

Engerix-B

Serious events: 148 serious events

Other events: 549 other events

Deaths: 0 deaths

Serious adverse events

Measure	HEPLISAV n=5587 participants at risk 0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) HEPLISAV and/or Placebo: Intramuscular (IM) injections at Week 0, Week 4, plus a placebo (saline) injection at Week 24	Engerix-B n=2781 participants at risk 1.0 mL Engerix-B Engerix-B: Intramuscular injections at Week 0, Week 4, and Week 24
Psychiatric disorders Substance-induced psychotic disorder	0.00% 0/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Nervous system disorders Embolic stroke	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Nervous system disorders Haemorrhagic stroke	0.00% 0/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Nervous system disorders Headache	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Nervous system disorders Hepatic encephalopathy	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Nervous system disorders Hypoaesthesia	0.00% 0/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Nervous system disorders Hypoxic-ischaemic encephalopathy	0.04% 2/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Nervous system disorders Ischaemic stroke	0.04% 2/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Nervous system disorders Lacunar infarction	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Nervous system disorders Lumbar radiculopathy	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Nervous system disorders Migraine	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Nervous system disorders Neuropathy peripheral	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Nervous system disorders Radial nerve palsy	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Nervous system disorders Spondylitic myelopathy	0.00% 0/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Nervous system disorders Subarachnoid haemorrhage	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Nervous system disorders Syncope	0.04% 2/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.14% 4/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Nervous system disorders Thalamic infarction	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Nervous system disorders Thrombotic stroke	0.00% 0/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Nervous system disorders Transient global amnesia	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Nervous system disorders Transient ischaemic attack	0.07% 4/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.05% 3/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.07% 2/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Pregnancy, puerperium and perinatal conditions Foetal growth restriction	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Pregnancy, puerperium and perinatal conditions Gestational diabetes	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Pregnancy, puerperium and perinatal conditions Oligohydramnios	0.00% 0/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Pregnancy, puerperium and perinatal conditions Placenta praevia	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Psychiatric disorders Bipolar disorder	0.05% 3/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Psychiatric disorders Bipolar i disorder	0.07% 4/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Psychiatric disorders Confusional state	0.00% 0/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Psychiatric disorders Delirium	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Psychiatric disorders Depression	0.09% 5/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Psychiatric disorders Depression suicidal	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Psychiatric disorders Mental status changes	0.05% 3/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Psychiatric disorders Schizoaffective disorder	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Psychiatric disorders Schizophrenia	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Psychiatric disorders Suicidal ideation	0.05% 3/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Psychiatric disorders Suicide attempt	0.05% 3/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Renal and urinary disorders Acute prerenal failure	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Renal and urinary disorders Bladder disorder	0.00% 0/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Renal and urinary disorders Calculus ureteric	0.07% 4/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.07% 2/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Renal and urinary disorders Nephrolithiasis	0.00% 0/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Renal and urinary disorders Prerenal failure	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Renal and urinary disorders Renal failure	0.00% 0/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Renal and urinary disorders Renal failure acute	0.07% 4/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.11% 3/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Renal and urinary disorders Renal failure chronic	0.04% 2/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Renal and urinary disorders Tubulointerstitial nephritis	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Renal and urinary disorders Urinary retention	0.00% 0/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.07% 2/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Reproductive system and breast disorders Adenomyosis	0.00% 0/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.07% 2/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Reproductive system and breast disorders Cystocele	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Reproductive system and breast disorders Dysfunctional uterine bleeding	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Reproductive system and breast disorders Postmenopausal haemorrhage	0.00% 0/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Reproductive system and breast disorders Prostatitis	0.00% 0/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.11% 6/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Respiratory, thoracic and mediastinal disorders Asthma	0.09% 5/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.16% 9/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.11% 3/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Respiratory, thoracic and mediastinal disorders Diaphragmatic paralysis	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Respiratory, thoracic and mediastinal disorders Diaphragmatic rupture	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.04% 2/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Respiratory, thoracic and mediastinal disorders Hiccups	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.04% 2/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Respiratory, thoracic and mediastinal disorders Nasal polyps	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.04% 2/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.07% 4/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.05% 3/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.07% 2/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.00% 0/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.07% 2/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Skin and subcutaneous tissue disorders Diabetic foot	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.07% 2/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Skin and subcutaneous tissue disorders Hidradenitis	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Social circumstances Victim of homicide	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Vascular disorders Aortic aneurysm	0.04% 2/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Vascular disorders Aortic stenosis	0.00% 0/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Vascular disorders Deep vein thrombosis	0.07% 4/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.11% 3/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Vascular disorders Hypertension	0.09% 5/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.11% 3/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Vascular disorders Hypertensive crisis	0.04% 2/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Vascular disorders Hypotension	0.04% 2/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.07% 2/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Vascular disorders Peripheral vascular disorder	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Vascular disorders Thrombophlebitis superficial	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Blood and lymphatic system disorders Anaemia	0.04% 2/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Blood and lymphatic system disorders Anaemia vitamin b12 deficiency	0.00% 0/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Blood and lymphatic system disorders Leukocytosis	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Blood and lymphatic system disorders Microcytic anaemia	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Cardiac disorders Acute coronary syndrome	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Cardiac disorders Acute myocardial infarction	0.25% 14/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Cardiac disorders Angina pectoris	0.04% 2/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Cardiac disorders Angina unstable	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Cardiac disorders Atrial fibrillation	0.11% 6/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.11% 3/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Cardiac disorders Atrial flutter	0.04% 2/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Cardiac disorders Bradycardia	0.04% 2/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Cardiac disorders Cardiac arrest	0.05% 3/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Cardiac disorders Cardiac failure	0.04% 2/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Cardiac disorders Cardiac failure acute	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Cardiac disorders Cardiac failure congestive	0.11% 6/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.11% 3/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Cardiac disorders Cardiac ventricular thrombosis	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Cardiac disorders Cardio-respiratory arrest	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Cardiac disorders Cardiogenic shock	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Cardiac disorders Cardiomyopathy	0.00% 0/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Cardiac disorders Coronary artery disease	0.11% 6/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.07% 2/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Cardiac disorders Coronary artery occlusion	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Cardiac disorders Coronary artery stenosis	0.04% 2/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Cardiac disorders Hypertensive heart disease	0.07% 4/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Cardiac disorders Myocardial infarction	0.04% 2/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Cardiac disorders Myocardial ischaemia	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Cardiac disorders Pulseless electrical activity	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Cardiac disorders Supraventricular tachycardia	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Cardiac disorders Ventricular fibrillation	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Cardiac disorders Ventricular tachycardia	0.04% 2/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Congenital, familial and genetic disorders Atrial septal defect	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Congenital, familial and genetic disorders Ebstein's anomaly	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Congenital, familial and genetic disorders Sickle cell anaemia with crisis	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Ear and labyrinth disorders Vertigo	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Ear and labyrinth disorders Vertigo positional	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Endocrine disorders Inappropriate antidiuretic hormone secretion	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Endocrine disorders Pituitary-dependent cushing's syndrome	0.00% 0/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Endocrine disorders Thyroid mass	0.00% 0/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Gastrointestinal disorders Abdominal hernia	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Gastrointestinal disorders Abdominal pain	0.04% 2/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.07% 2/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Gastrointestinal disorders Appendix disorder	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Gastrointestinal disorders Colitis	0.04% 2/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Gastrointestinal disorders Colitis ulcerative	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Gastrointestinal disorders Constipation	0.04% 2/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Gastrointestinal disorders Cyclic vomiting syndrome	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Gastrointestinal disorders Diarrhoea	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Gastrointestinal disorders Diverticular perforation	0.04% 2/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Gastrointestinal disorders Diverticulum intestinal haemorrhagic	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.00% 0/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Gastrointestinal disorders Gastric ulcer	0.00% 0/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Gastrointestinal disorders Gastritis	0.04% 2/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Gastrointestinal disorders Gastritis alcoholic	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Gastrointestinal disorders Gastritis alcoholic haemorrhagic	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Gastrointestinal disorders Gastritis haemorrhagic	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.04% 2/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.05% 3/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Gastrointestinal disorders Ileus	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Gastrointestinal disorders Ileus paralytic	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Gastrointestinal disorders Impaired gastric emptying	0.00% 0/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Gastrointestinal disorders Inguinal hernia	0.00% 0/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Gastrointestinal disorders Large intestine perforation	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Gastrointestinal disorders Oesophageal spasm	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Gastrointestinal disorders Oesophagitis	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Gastrointestinal disorders Pancreatitis	0.04% 2/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Gastrointestinal disorders Pancreatitis acute	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.07% 2/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Gastrointestinal disorders Rectal haemorrhage	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.07% 2/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Gastrointestinal disorders Rectal prolapse	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Gastrointestinal disorders Small intestinal obstruction	0.11% 6/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.07% 2/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.04% 2/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Gastrointestinal disorders Varices oesophageal	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
General disorders Chest pain	0.04% 2/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
General disorders Death	0.04% 2/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
General disorders Device failure	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
General disorders Drug withdrawal syndrome	0.00% 0/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
General disorders Non-cardiac chest pain	0.16% 9/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.25% 7/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Hepatobiliary disorders Bile duct stone	0.04% 2/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Hepatobiliary disorders Cholecystitis	0.09% 5/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.07% 2/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.07% 2/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Hepatobiliary disorders Cholecystitis chronic	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.07% 2/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Hepatobiliary disorders Cholelithiasis	0.07% 4/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.14% 4/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Hepatobiliary disorders Hepatic cirrhosis	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Hepatobiliary disorders Ischaemic hepatitis	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Immune system disorders Hypersensitivity	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Infections and infestations Abscess limb	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Infections and infestations Abscess neck	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Infections and infestations Appendicitis	0.05% 3/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Infections and infestations Appendicitis perforated	0.04% 2/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Infections and infestations Arthritis bacterial	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Infections and infestations Bacteraemia	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Infections and infestations Bronchitis	0.05% 3/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Infections and infestations Cellulitis	0.13% 7/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.14% 4/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Infections and infestations Cellulitis of male external genital organ	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Infections and infestations Cellulitis orbital	0.00% 0/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Infections and infestations Cholecystitis infective	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Infections and infestations Clostridium difficile colitis	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Infections and infestations Device related infection	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Infections and infestations Diabetic foot infection	0.04% 2/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Infections and infestations Diverticulitis	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.07% 2/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Infections and infestations Erysipelas	0.00% 0/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Infections and infestations Gastroenteritis	0.07% 4/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Infections and infestations Gastroenteritis viral	0.00% 0/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Infections and infestations Groin abscess	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Infections and infestations Hepatitis c	0.04% 2/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Infections and infestations Infectious colitis	0.04% 2/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Infections and infestations Influenza	0.04% 2/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Infections and infestations Latent tuberculosis	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Infections and infestations Lobar pneumonia	0.04% 2/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Infections and infestations Meningitis	0.04% 2/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Infections and infestations Mycobacterium avium complex infection	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Infections and infestations Osteomyelitis	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Infections and infestations Otitis media bacterial	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Infections and infestations Periorbital cellulitis	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Infections and infestations Perirectal abscess	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Infections and infestations Pneumonia	0.27% 15/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.29% 8/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Infections and infestations Pneumonia escherichia	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm benign	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Infections and infestations Pneumonia staphylococcal	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Infections and infestations Post procedural infection	0.00% 0/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Infections and infestations Postoperative wound infection	0.00% 0/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Infections and infestations Pyelonephritis	0.04% 2/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Infections and infestations Pyelonephritis acute	0.04% 2/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Infections and infestations Sepsis	0.09% 5/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Infections and infestations Splenic abscess	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Infections and infestations Staphylococcal abscess	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Infections and infestations Staphylococcal osteomyelitis	0.00% 0/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Infections and infestations Upper respiratory tract infection	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Infections and infestations Urinary tract infection	0.00% 0/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Infections and infestations Urinary tract infection enterococcal	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Infections and infestations Urosepsis	0.07% 4/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.07% 2/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Infections and infestations Viral sepsis	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Infections and infestations Wound infection	0.00% 0/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Infections and infestations Wound infection staphylococcal	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Injury, poisoning and procedural complications Accident	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Injury, poisoning and procedural complications Accidental overdose	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Injury, poisoning and procedural complications Ankle fracture	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Injury, poisoning and procedural complications Arterial injury	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Injury, poisoning and procedural complications Concussion	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Injury, poisoning and procedural complications Craniocerebral injury	0.00% 0/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.07% 2/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Injury, poisoning and procedural complications Femur fracture	0.04% 2/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Injury, poisoning and procedural complications Foot fracture	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Injury, poisoning and procedural complications Forearm fracture	0.00% 0/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Injury, poisoning and procedural complications Gastrointestinal anastomotic leak	0.00% 0/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Injury, poisoning and procedural complications Gun shot wound	0.05% 3/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Injury, poisoning and procedural complications Hand fracture	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Injury, poisoning and procedural complications Head injury	0.00% 0/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.04% 2/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Injury, poisoning and procedural complications Hip fracture	0.04% 2/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Injury, poisoning and procedural complications Humerus fracture	0.04% 2/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Injury, poisoning and procedural complications Intentional overdose	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Injury, poisoning and procedural complications Jaw fracture	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma	0.00% 0/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Injury, poisoning and procedural complications Laceration	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Injury, poisoning and procedural complications Lower limb fracture	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.04% 2/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Injury, poisoning and procedural complications Overdose	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Injury, poisoning and procedural complications Patella fracture	0.04% 2/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Injury, poisoning and procedural complications Peripheral nerve injury	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Injury, poisoning and procedural complications Post procedural haematoma	0.04% 2/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholangiocarcinoma	0.00% 0/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Injury, poisoning and procedural complications Postoperative fever	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Injury, poisoning and procedural complications Postoperative ileus	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Injury, poisoning and procedural complications Procedural intestinal perforation	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.07% 2/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Injury, poisoning and procedural complications Rib fracture	0.04% 2/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Injury, poisoning and procedural complications Scapula fracture	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Injury, poisoning and procedural complications Seroma	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Injury, poisoning and procedural complications Spinal fracture	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Injury, poisoning and procedural complications Stab wound	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Injury, poisoning and procedural complications Tibia fracture	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Injury, poisoning and procedural complications Toxicity to various agents	0.09% 5/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Injury, poisoning and procedural complications Traumatic haemothorax	0.00% 0/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Injury, poisoning and procedural complications Urinary retention postoperative	0.00% 0/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Investigations Electrophoresis protein abnormal	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Investigations Foetal heart rate abnormal	0.00% 0/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Investigations International normalised ratio increased	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Metabolism and nutrition disorders Dehydration	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.11% 3/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.04% 2/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.09% 5/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Metabolism and nutrition disorders Dyslipidaemia	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Metabolism and nutrition disorders Hypoglycaemia	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Metabolism and nutrition disorders Hypokalaemia	0.04% 2/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.07% 2/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Metabolism and nutrition disorders Hyponatraemia	0.04% 2/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Musculoskeletal and connective tissue disorders Back pain	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Musculoskeletal and connective tissue disorders Bursitis	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Musculoskeletal and connective tissue disorders Costochondritis	0.00% 0/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Clear cell renal cell carcinoma	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.04% 2/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ductal adenocarcinoma of pancreas	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.04% 2/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Musculoskeletal and connective tissue disorders Muscular weakness	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.13% 7/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.11% 3/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.04% 2/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.04% 2/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Musculoskeletal and connective tissue disorders Vertebral foraminal stenosis	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's disease	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal papillary mucinous neoplasm	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal proliferative breast lesion	0.04% 2/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.04% 2/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic renal cell carcinoma	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal adenocarcinoma	0.00% 0/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer stage iii	0.00% 0/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian germ cell teratoma	0.00% 0/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma metastatic	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.00% 0/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pelvic neoplasm	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.05% 3/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.14% 4/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer stage ii	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenocarcinoma	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer metastatic	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the cervix	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the oral cavity	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.07% 2/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Nervous system disorders Carotid artery stenosis	0.04% 2/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Nervous system disorders Carotid sinus syndrome	0.00% 0/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Nervous system disorders Cauda equina syndrome	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Nervous system disorders Cerebrovascular accident	0.13% 7/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.11% 3/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Nervous system disorders Cervical myelopathy	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Nervous system disorders Complex partial seizures	0.02% 1/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Nervous system disorders Convulsion	0.07% 4/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.04% 1/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Nervous system disorders Dizziness	0.04% 2/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	0.00% 0/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.

Other adverse events

Measure	HEPLISAV n=5587 participants at risk 0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) HEPLISAV and/or Placebo: Intramuscular (IM) injections at Week 0, Week 4, plus a placebo (saline) injection at Week 24	Engerix-B n=2781 participants at risk 1.0 mL Engerix-B Engerix-B: Intramuscular injections at Week 0, Week 4, and Week 24
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.81% 45/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	1.1% 30/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Musculoskeletal and connective tissue disorders Osteoarthritis	1.3% 72/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	1.1% 30/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Infections and infestations Acute sinusitis	1.1% 59/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	1.3% 37/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Infections and infestations Bronchitis	3.1% 174/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	3.7% 102/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Infections and infestations Sinusitis	2.7% 149/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	3.0% 84/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Infections and infestations Upper respiratory tract infection	3.4% 191/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	3.3% 92/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Infections and infestations Urinary tract infection	2.4% 132/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	2.3% 63/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Metabolism and nutrition disorders Type 2 diabetes mellitus	1.2% 66/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	1.3% 36/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Musculoskeletal and connective tissue disorders Arthralgia	1.8% 98/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	1.9% 54/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Musculoskeletal and connective tissue disorders Back pain	2.1% 115/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	1.9% 54/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Musculoskeletal and connective tissue disorders Pain in extremity	1.3% 72/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	1.0% 28/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Respiratory, thoracic and mediastinal disorders Cough	1.1% 62/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	1.3% 37/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
Vascular disorders Hypertension	2.3% 128/5587 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.	2.0% 57/2781 • Through Week 56 Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.

Additional Information

Robert Janssen MD \ VP & Chief Medical Officer

Dynavax Technologies, Inc.

Phone: 510-848-5100

Results disclosure agreements

• Principal investigator is a sponsor employee Principal Investigator may communicate study results with prior written consent from Dynavax.
• Publication restrictions are in place

Restriction type: OTHER