Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Rivaroxaban Venous Thromboembolism (VTE) Prophylaxis in Ambulatory Cancer Participants (NCT NCT02555878)

NCT ID: NCT02555878

Last Updated: 2019-09-12

Results Overview

Percentage of participants with time to the first occurrence of primary efficacy endpoint (composite and components) was reported. The primary efficacy composite endpoint is time to first occurrence of objectively confirmed symptomatic and asymptomatic lower extremity proximal DVT, symptomatic lower extremity distal DVT, symptomatic upper extremity DVT, symptomatic non-fatal PE, incidental PE, or VTE-related death as adjudicated by an independent blinded Clinical Endpoint Committee (CEC).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 841 participants
• Primary outcome timeframe: Up to Day 180
• Results posted on: 2019-09-12

Participant Flow

A total of 841 participants were enrolled in the study to receive either of the 2 treatments: rivaroxaban or matching placebo.

Deaths which were primary cause of treatment discontinuation (up to Day 180) are reported in participant flow excluding deaths which occurred after discontinuation.

Participant milestones

Measure	Placebo Participants received placebo tablet matched to rivaroxaban orally once daily for 180 days.	Rivaroxaban 10 mg Participants received rivaroxaban 10 milligram (mg) tablet orally once daily for 180 days.
Overall Study STARTED	421	420
Overall Study Treated	404	405
Overall Study COMPLETED	255	270
Overall Study NOT COMPLETED	166	150

Reasons for withdrawal

Measure	Placebo Participants received placebo tablet matched to rivaroxaban orally once daily for 180 days.	Rivaroxaban 10 mg Participants received rivaroxaban 10 milligram (mg) tablet orally once daily for 180 days.
Overall Study Lost to Follow-up	2	3
Overall Study Withdrawal by Subject	48	48
Overall Study Adverse Event	12	8
Overall Study Death	74	59
Overall Study Protocol Violation	1	2
Overall Study Physician Decision	12	13
Overall Study Other	17	17

Baseline Characteristics

A Study to Evaluate the Efficacy and Safety of Rivaroxaban Venous Thromboembolism (VTE) Prophylaxis in Ambulatory Cancer Participants

Baseline characteristics by cohort

Measure	Placebo n=421 Participants Participants received placebo tablet matched to rivaroxaban orally once daily for 180 days.	Rivaroxaban 10 mg n=420 Participants Participants received rivaroxaban 10 milligram (mg) tablet orally once daily for 180 days.	Total n=841 Participants Total of all reporting groups
Age, Continuous	61.9 years STANDARD_DEVIATION 11.19 • n=5 Participants	62.1 years STANDARD_DEVIATION 11.22 • n=7 Participants	62 years STANDARD_DEVIATION 11.2 • n=5 Participants
Sex: Female, Male Female	215 Participants n=5 Participants	198 Participants n=7 Participants	413 Participants n=5 Participants
Sex: Female, Male Male	206 Participants n=5 Participants	222 Participants n=7 Participants	428 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	69 Participants n=5 Participants	63 Participants n=7 Participants	132 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	312 Participants n=5 Participants	314 Participants n=7 Participants	626 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	40 Participants n=5 Participants	43 Participants n=7 Participants	83 Participants n=5 Participants
Race/Ethnicity, Customized White	346 Count of Participants n=5 Participants	352 Count of Participants n=7 Participants	698 Count of Participants n=5 Participants
Race/Ethnicity, Customized Black	18 Count of Participants n=5 Participants	13 Count of Participants n=7 Participants	31 Count of Participants n=5 Participants
Race/Ethnicity, Customized Asian	5 Count of Participants n=5 Participants	6 Count of Participants n=7 Participants	11 Count of Participants n=5 Participants
Race/Ethnicity, Customized Other	21 Count of Participants n=5 Participants	10 Count of Participants n=7 Participants	31 Count of Participants n=5 Participants
Race/Ethnicity, Customized Not reported	31 Count of Participants n=5 Participants	39 Count of Participants n=7 Participants	70 Count of Participants n=5 Participants
Region of Enrollment Belgium	3 Participants n=5 Participants	10 Participants n=7 Participants	13 Participants n=5 Participants
Region of Enrollment Brazil	55 Participants n=5 Participants	48 Participants n=7 Participants	103 Participants n=5 Participants
Region of Enrollment Bulgaria	15 Participants n=5 Participants	19 Participants n=7 Participants	34 Participants n=5 Participants
Region of Enrollment Canada	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment Czech Republic	25 Participants n=5 Participants	12 Participants n=7 Participants	37 Participants n=5 Participants
Region of Enrollment France	29 Participants n=5 Participants	34 Participants n=7 Participants	63 Participants n=5 Participants
Region of Enrollment Germany	60 Participants n=5 Participants	53 Participants n=7 Participants	113 Participants n=5 Participants
Region of Enrollment Italy	17 Participants n=5 Participants	15 Participants n=7 Participants	32 Participants n=5 Participants
Region of Enrollment Russian Federation	59 Participants n=5 Participants	61 Participants n=7 Participants	120 Participants n=5 Participants
Region of Enrollment United Kingdom	30 Participants n=5 Participants	19 Participants n=7 Participants	49 Participants n=5 Participants
Region of Enrollment United States of America	128 Participants n=5 Participants	146 Participants n=7 Participants	274 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to Day 180

Population: The Intent-to-treat (ITT) population consisted of all randomized participants.

Percentage of participants with time to the first occurrence of primary efficacy endpoint (composite and components) was reported. The primary efficacy composite endpoint is time to first occurrence of objectively confirmed symptomatic and asymptomatic lower extremity proximal DVT, symptomatic lower extremity distal DVT, symptomatic upper extremity DVT, symptomatic non-fatal PE, incidental PE, or VTE-related death as adjudicated by an independent blinded Clinical Endpoint Committee (CEC).

Outcome measures

Measure	Placebo n=421 Participants Participants received placebo tablet matched to rivaroxaban orally once daily for 180 days.	Rivaroxaban 10 mg n=420 Participants Participants received rivaroxaban 10 milligram (mg) tablet orally once daily for 180 days.
Percentage of Participants With Time to First Occurrence of Primary Efficacy Endpoint (Composite and Components) Primary efficacy composite endpoint	8.79 Percentage of participants	5.95 Percentage of participants
Percentage of Participants With Time to First Occurrence of Primary Efficacy Endpoint (Composite and Components) Symptomatic lower extremity proximal DVT	1.90 Percentage of participants	2.14 Percentage of participants
Percentage of Participants With Time to First Occurrence of Primary Efficacy Endpoint (Composite and Components) Symptomatic lower extremity distal DVT	1.19 Percentage of participants	0.48 Percentage of participants
Percentage of Participants With Time to First Occurrence of Primary Efficacy Endpoint (Composite and Components) Symptomatic upper extremity DVT	1.43 Percentage of participants	0.95 Percentage of participants
Percentage of Participants With Time to First Occurrence of Primary Efficacy Endpoint (Composite and Components) Symptomatic non-fatal PE	1.19 Percentage of participants	1.19 Percentage of participants
Percentage of Participants With Time to First Occurrence of Primary Efficacy Endpoint (Composite and Components) Asymptomatic lower extremity proximal DVT	2.61 Percentage of participants	0.95 Percentage of participants
Percentage of Participants With Time to First Occurrence of Primary Efficacy Endpoint (Composite and Components) Incidental PE	2.38 Percentage of participants	1.43 Percentage of participants
Percentage of Participants With Time to First Occurrence of Primary Efficacy Endpoint (Composite and Components) VTE-related death	0.71 Percentage of participants	0.24 Percentage of participants

PRIMARY outcome

Timeframe: From first dose of study drug to 2 days after the last dose of the study drug (up to 32 weeks)

Population: The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug.

Major bleeding is defined as clinically overt bleeding that is associated with a reduction in hemoglobin of 2 gram per deciliter (g/dL) or more, or a transfusion of 2 or more units of packed red blood cells or whole blood, or occurrence at a critical site defined as intracranial, intra-spinal, intraocular, pericardial, intra-articular, intra-muscular with compartment syndrome, retroperitoneal, or fatal outcome.

Outcome measures

Measure	Placebo n=404 Participants Participants received placebo tablet matched to rivaroxaban orally once daily for 180 days.	Rivaroxaban 10 mg n=405 Participants Participants received rivaroxaban 10 milligram (mg) tablet orally once daily for 180 days.
Percentage of Participants With Time to the First Occurrence of Major Bleeding Events as Defined by International Society of Thrombosis and Haemostasis (ISTH)	0.99 Percentage of participants	1.98 Percentage of participants

SECONDARY outcome

Timeframe: Up to Day 180

Population: The ITT population consisted of all randomized participants.

Percentage of participants with time to first occurrence of the composite endpoint of symptomatic VTE events (symptomatic lower extremity proximal DVT, symptomatic lower extremity distal DVT, symptomatic upper extremity DVT, or symptomatic non-fatal PE) or VTE related deaths as adjudicated by an independent blinded CEC up-to-Day 180 observation period was reported.

Outcome measures

Measure	Placebo n=421 Participants Participants received placebo tablet matched to rivaroxaban orally once daily for 180 days.	Rivaroxaban 10 mg n=420 Participants Participants received rivaroxaban 10 milligram (mg) tablet orally once daily for 180 days.
Percentage of Participants With Time to the First Occurrence of Symptomatic VTE Events or VTE-Related Deaths	5.23 Percentage of participants	3.81 Percentage of participants

SECONDARY outcome

Timeframe: Up to Day 180

Population: The ITT population consisted of all randomized participants.

Percentage of participants with all-cause mortality as adjudicated by an independent blinded CEC up-to-Day 180 observation period was reported. Overall deaths occurred during observation period (defined by start to end date of the observation period [that is approximately 180 days] are reported here.

Outcome measures

Measure	Placebo n=421 Participants Participants received placebo tablet matched to rivaroxaban orally once daily for 180 days.	Rivaroxaban 10 mg n=420 Participants Participants received rivaroxaban 10 milligram (mg) tablet orally once daily for 180 days.
Percentage of Participants With All-Cause Mortality	23.8 Percentage of participants	20.0 Percentage of participants

SECONDARY outcome

Timeframe: Up to Day 180

Population: The ITT population consisted of all randomized participants.

Percentage of participants with time to first occurrence of fatal/non-fatal ATE (a composite of occurrence of myocardial infarction (MI), stroke [ischemic infarction with or without hemorrhagic conversion or primary hemorrhagic events - intraparenchymal hemorrhage, subdural hematoma or epidural hematoma] or any other ATE recorded) event as adjudicated by an independent blinded CEC up-to-Day 180 observation period was reported.

Outcome measures

Measure	Placebo n=421 Participants Participants received placebo tablet matched to rivaroxaban orally once daily for 180 days.	Rivaroxaban 10 mg n=420 Participants Participants received rivaroxaban 10 milligram (mg) tablet orally once daily for 180 days.
Percentage of Participants With Time to the First Occurrence of Fatal or Non-fatal Arterial Thromboembolic Events (ATE)	1.66 Percentage of participants	0.95 Percentage of participants

SECONDARY outcome

Timeframe: Up to Day 180

Population: The ITT population consisted of all randomized participants.

Percentage of participants with time to the first occurrence of fatal or non-fatal visceral VTE as adjudicated by an independent blinded CEC up-to-Day 180 observation period was reported.

Outcome measures

Measure	Placebo n=421 Participants Participants received placebo tablet matched to rivaroxaban orally once daily for 180 days.	Rivaroxaban 10 mg n=420 Participants Participants received rivaroxaban 10 milligram (mg) tablet orally once daily for 180 days.
Percentage of Participants With Time to the First Occurrence of Fatal or Non-fatal Visceral VTE	0.48 Percentage of participants	0.24 Percentage of participants

SECONDARY outcome

Timeframe: Up to Day 180

Population: The ITT population consisted of all randomized participants.

Percentage of participants with time to first occurrence of composite efficacy endpoint 1 (composite of objectively confirmed symptomatic and asymptomatic lower extremity proximal DVT, symptomatic lower extremity distal DVT, symptomatic upper extremity DVT, symptomatic non-fatal PE, incidental PE or all-cause mortality) as adjudicated by an independent blinded CEC up-to-Day 180 observation period was reported.

Outcome measures

Measure	Placebo n=421 Participants Participants received placebo tablet matched to rivaroxaban orally once daily for 180 days.	Rivaroxaban 10 mg n=420 Participants Participants received rivaroxaban 10 milligram (mg) tablet orally once daily for 180 days.
Percentage of Participants With Time to the First Occurrence of Composite Efficacy Endpoint 1	29.5 Percentage of participants	23.1 Percentage of participants

SECONDARY outcome

Timeframe: Up to Day 180

Population: The ITT population consisted of all randomized participants.

Percentage of participants with time to first occurrence of composite efficacy endpoint 2 (composite of objectively confirmed symptomatic lower extremity proximal DVT, symptomatic lower extremity distal DVT, symptomatic upper extremity DVT, symptomatic non-fatal PE or VTE-related deaths) as adjudicated by an independent blinded CEC up-to-Day 180 observation period was reported.

Outcome measures

Measure	Placebo n=421 Participants Participants received placebo tablet matched to rivaroxaban orally once daily for 180 days.	Rivaroxaban 10 mg n=420 Participants Participants received rivaroxaban 10 milligram (mg) tablet orally once daily for 180 days.
Percentage of Participants With Time to First Occurrence of Composite Efficacy Endpoint 2	5.23 Percentage of participants	3.81 Percentage of participants

SECONDARY outcome

Timeframe: Up to Day 180

Population: The ITT population consisted of all randomized participants.

Percentage of participants with time to first occurrence of composite efficacy endpoint 3 (composite of objectively confirmed symptomatic lower extremity proximal DVT, symptomatic lower extremity distal DVT, symptomatic upper extremity DVT, asymptomatic lower extremity proximal DVT, symptomatic non-fatal PE, incidental PE, VTE-related deaths, fatal/non-fatal ATE [MI, stroke {ischemic infarction with or without hemorrhagic conversion or primary hemorrhagic events - intraparenchymal hemorrhage, subdural hematoma or epidural hematoma} or any ATE] or fatal/non-fatal visceral VTE) as adjudicated by an independent blinded CEC up-to-Day 180 observation period was reported.

Outcome measures

Measure	Placebo n=421 Participants Participants received placebo tablet matched to rivaroxaban orally once daily for 180 days.	Rivaroxaban 10 mg n=420 Participants Participants received rivaroxaban 10 milligram (mg) tablet orally once daily for 180 days.
Percentage of Participants With Time to First Occurrence of Composite Efficacy Endpoint 3	10.7 Percentage of participants	6.90 Percentage of participants

SECONDARY outcome

Timeframe: Up to Day 180

Population: The ITT population consisted of all randomized participants.

Percentage of participants with time to first occurrence of composite efficacy endpoint 4 (composite of objectively confirmed symptomatic lower extremity proximal DVT, symptomatic lower extremity distal DVT, symptomatic upper extremity DVT, symptomatic non-fatal PE, VTE-related deaths or major bleeding events up to Day 180) as adjudicated by an independent blinded CEC up-to-Day 180 observation period was reported.

Outcome measures

Measure	Placebo n=421 Participants Participants received placebo tablet matched to rivaroxaban orally once daily for 180 days.	Rivaroxaban 10 mg n=420 Participants Participants received rivaroxaban 10 milligram (mg) tablet orally once daily for 180 days.
Percentage of Participants With Time to First Occurrence of Composite Efficacy Endpoint 4	6.89 Percentage of participants	5.71 Percentage of participants

SECONDARY outcome

Timeframe: From first dose of study drug to 2 days after the last dose of the study drug (up to 32 weeks)

Population: The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug.

Percentage of participants with time to the first occurrence of clinically relevant non-major bleeding was reported. Clinically relevant non-major bleeding is defined as overt bleeding not meeting the criteria for major bleeding but associated with medical intervention, or unscheduled contact with a physician, or temporary cessation of study treatment, or discomfort such as pain, or impairment of activities of daily life.

Outcome measures

Measure	Placebo n=404 Participants Participants received placebo tablet matched to rivaroxaban orally once daily for 180 days.	Rivaroxaban 10 mg n=405 Participants Participants received rivaroxaban 10 milligram (mg) tablet orally once daily for 180 days.
Percentage of Participants With Time to the First Occurrence of Clinically Relevant Non-major Bleeding	1.98 Percentage of participants	2.72 Percentage of participants

SECONDARY outcome

Timeframe: From first dose of study drug to 2 days after the last dose of the study drug (up to 32 weeks)

Population: The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug.

Percentage of participants with time to the first occurrence of minor bleeding was reported. Minor bleeding (that is, minimal bleeding) is defined as overt bleeding episodes not meeting the criteria for major or clinically relevant non-major bleeding event.

Outcome measures

Measure	Placebo n=404 Participants Participants received placebo tablet matched to rivaroxaban orally once daily for 180 days.	Rivaroxaban 10 mg n=405 Participants Participants received rivaroxaban 10 milligram (mg) tablet orally once daily for 180 days.
Percentage of Participants With Time to the First Occurrence of Minor Bleeding	3.96 Percentage of participants	6.91 Percentage of participants

SECONDARY outcome

Timeframe: From first dose of study drug to 2 days after the last dose of the study drug (up to 32 weeks)

Population: The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug.

Percentage of participants with time to the first occurrence of any bleeding event was reported. Any bleeding is defined as a composite of major bleeding, clinically relevant non-major bleeding, or minor bleeding.

Outcome measures

Measure	Placebo n=404 Participants Participants received placebo tablet matched to rivaroxaban orally once daily for 180 days.	Rivaroxaban 10 mg n=405 Participants Participants received rivaroxaban 10 milligram (mg) tablet orally once daily for 180 days.
Percentage of Participants With Time to the First Occurrence of Any Bleeding	6.44 Percentage of participants	11.1 Percentage of participants

Adverse Events

Placebo

Serious events: 128 serious events

Other events: 145 other events

Deaths: 106 deaths

Rivaroxaban 10 mg

Serious events: 134 serious events

Other events: 138 other events

Deaths: 85 deaths

Serious adverse events

Measure	Placebo n=404 participants at risk Participants received placebo tablet matched to rivaroxaban orally once daily for 180 days.	Rivaroxaban 10 mg n=405 participants at risk Participants received rivaroxaban 10 milligram (mg) tablet orally once daily for 180 days.
Blood and lymphatic system disorders Anaemia	0.74% 3/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.74% 3/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Blood and lymphatic system disorders Febrile Neutropenia	0.99% 4/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	1.5% 6/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Blood and lymphatic system disorders Leukopenia	0.25% 1/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.00% 0/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Blood and lymphatic system disorders Neutropenia	0.74% 3/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.25% 1/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Blood and lymphatic system disorders Pancytopenia	0.25% 1/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.00% 0/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Blood and lymphatic system disorders Thrombocytopenia	0.50% 2/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.00% 0/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Cardiac disorders Atrial Fibrillation	0.50% 2/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.25% 1/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Cardiac disorders Cardiotoxicity	0.00% 0/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.25% 1/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Cardiac disorders Coronary Artery Disease	0.00% 0/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.25% 1/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Cardiac disorders Pericardial Effusion	0.25% 1/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.00% 0/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Cardiac disorders Supraventricular Tachycardia	0.00% 0/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.25% 1/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Endocrine disorders Inappropriate Antidiuretic Hormone Secretion	0.00% 0/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.25% 1/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Gastrointestinal disorders Abdominal Pain	0.74% 3/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	1.2% 5/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Gastrointestinal disorders Abdominal Pain Upper	0.25% 1/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.00% 0/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Gastrointestinal disorders Ascites	0.00% 0/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.25% 1/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Gastrointestinal disorders Constipation	0.00% 0/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.25% 1/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Gastrointestinal disorders Diarrhoea	0.50% 2/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.49% 2/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Gastrointestinal disorders Duodenal Obstruction	0.00% 0/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.74% 3/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Gastrointestinal disorders Dyspepsia	0.00% 0/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.25% 1/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Gastrointestinal disorders Dysphagia	0.99% 4/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.25% 1/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Gastrointestinal disorders Enterocolitis	0.00% 0/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.25% 1/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Gastrointestinal disorders Faecaloma	0.00% 0/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.25% 1/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Gastrointestinal disorders Gastrointestinal Disorder	0.00% 0/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.25% 1/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Gastrointestinal disorders Gastrointestinal Obstruction	0.25% 1/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.00% 0/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Gastrointestinal disorders Gastrointestinal Perforation	0.25% 1/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.00% 0/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Gastrointestinal disorders Gastrointestinal Toxicity	0.00% 0/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.25% 1/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Gastrointestinal disorders Intestinal Infarction	0.00% 0/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.25% 1/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Gastrointestinal disorders Intestinal Ischaemia	0.00% 0/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.25% 1/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Gastrointestinal disorders Intestinal Obstruction	0.00% 0/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.25% 1/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Gastrointestinal disorders Nausea	0.50% 2/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.25% 1/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Gastrointestinal disorders Small Intestinal Obstruction	0.74% 3/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.74% 3/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Gastrointestinal disorders Vomiting	0.74% 3/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.49% 2/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
General disorders Chest Pain	0.25% 1/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.00% 0/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
General disorders Condition Aggravated	0.00% 0/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.25% 1/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
General disorders Death	0.50% 2/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.00% 0/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
General disorders Disease Progression	0.50% 2/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.00% 0/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
General disorders Fatigue	0.00% 0/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.25% 1/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
General disorders General Physical Health Deterioration	0.99% 4/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	1.2% 5/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
General disorders Generalised Oedema	0.25% 1/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.00% 0/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
General disorders Malaise	0.00% 0/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.49% 2/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
General disorders Mucosal Inflammation	0.25% 1/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.00% 0/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
General disorders Multiple Organ Dysfunction Syndrome	0.25% 1/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.00% 0/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
General disorders Non-Cardiac Chest Pain	0.25% 1/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.00% 0/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
General disorders Pyrexia	2.0% 8/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	2.0% 8/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Hepatobiliary disorders Bile Duct Obstruction	0.74% 3/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.25% 1/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Hepatobiliary disorders Cholangitis	0.25% 1/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.49% 2/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Hepatobiliary disorders Cholecystitis	0.25% 1/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.00% 0/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Hepatobiliary disorders Cholestasis	0.25% 1/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.25% 1/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Hepatobiliary disorders Hypertransaminasaemia	0.00% 0/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.25% 1/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Hepatobiliary disorders Jaundice	0.00% 0/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.25% 1/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Immune system disorders Drug Hypersensitivity	0.00% 0/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.25% 1/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Infections and infestations Abdominal Sepsis	0.25% 1/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.00% 0/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Infections and infestations Abscess Limb	0.00% 0/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.25% 1/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Infections and infestations Anal Abscess	0.00% 0/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.25% 1/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Infections and infestations Appendicitis	0.00% 0/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.25% 1/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Infections and infestations Atypical Pneumonia	0.50% 2/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.25% 1/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Infections and infestations Bacteraemia	0.25% 1/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.00% 0/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Infections and infestations Biliary Sepsis	0.50% 2/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.00% 0/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Infections and infestations Cellulitis	0.25% 1/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.74% 3/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Infections and infestations Cholecystitis Infective	0.25% 1/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.00% 0/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Infections and infestations Clostridium Difficile Colitis	0.25% 1/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.00% 0/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Infections and infestations Device Related Infection	0.00% 0/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.25% 1/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Infections and infestations Diverticulitis	0.50% 2/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.25% 1/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Infections and infestations Febrile Infection	0.25% 1/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.00% 0/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Infections and infestations Gastroenteritis Viral	0.25% 1/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.00% 0/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Infections and infestations Klebsiella Sepsis	0.25% 1/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.00% 0/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Infections and infestations Lower Respiratory Tract Infection	0.74% 3/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.00% 0/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Infections and infestations Lung Infection	0.25% 1/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.49% 2/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Infections and infestations Neutropenic Sepsis	0.74% 3/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.00% 0/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Infections and infestations Oral Candidiasis	0.00% 0/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.25% 1/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Infections and infestations Pneumonia	0.99% 4/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	2.5% 10/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Infections and infestations Pneumonia Bacterial	0.25% 1/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.00% 0/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Infections and infestations Respiratory Tract Infection	0.25% 1/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.00% 0/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Infections and infestations Sepsis	0.99% 4/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	1.5% 6/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Infections and infestations Septic Shock	0.25% 1/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.25% 1/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Infections and infestations Sinusitis	0.25% 1/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.00% 0/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Infections and infestations Tracheobronchitis	0.25% 1/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.00% 0/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Infections and infestations Urinary Tract Infection	0.50% 2/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.74% 3/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Injury, poisoning and procedural complications Hip Fracture	0.50% 2/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.00% 0/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Injury, poisoning and procedural complications Pubis Fracture	0.00% 0/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.25% 1/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Investigations Aspiration Bronchial	0.00% 0/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.25% 1/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Investigations Blood Bilirubin Increased	0.00% 0/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.49% 2/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Investigations General Physical Condition Abnormal	0.00% 0/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.25% 1/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Investigations Glomerular Filtration Rate Decreased	0.00% 0/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.25% 1/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Investigations Platelet Count Decreased	0.25% 1/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.00% 0/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Metabolism and nutrition disorders Decreased Appetite	0.25% 1/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.00% 0/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Metabolism and nutrition disorders Dehydration	1.2% 5/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.74% 3/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Metabolism and nutrition disorders Diabetic Ketoacidosis	0.00% 0/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.25% 1/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Metabolism and nutrition disorders Electrolyte Imbalance	0.25% 1/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.00% 0/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Metabolism and nutrition disorders Failure to Thrive	0.00% 0/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.25% 1/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Metabolism and nutrition disorders Feeding Intolerance	0.25% 1/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.00% 0/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.25% 1/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.49% 2/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Metabolism and nutrition disorders Hypokalaemia	0.25% 1/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.25% 1/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.25% 1/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Musculoskeletal and connective tissue disorders Back Pain	0.25% 1/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.49% 2/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Musculoskeletal and connective tissue disorders Bursitis	0.25% 1/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.00% 0/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Musculoskeletal and connective tissue disorders Muscle Tightness	0.25% 1/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.00% 0/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Musculoskeletal and connective tissue disorders Muscular Weakness	0.25% 1/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.49% 2/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	0.25% 1/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.00% 0/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Musculoskeletal and connective tissue disorders Pathological Fracture	0.25% 1/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.00% 0/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer Pain	0.25% 1/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.00% 0/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Adenocarcinoma	0.25% 1/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.00% 0/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Neoplasm Progression	8.2% 33/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	7.2% 29/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to Central Nervous System	0.25% 1/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.00% 0/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to Liver	0.00% 0/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.49% 2/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to Lymph Nodes	0.25% 1/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.00% 0/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm Progression	0.00% 0/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.25% 1/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian Cancer	0.25% 1/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.00% 0/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour Associated Fever	0.25% 1/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.00% 0/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Nervous system disorders Headache	0.25% 1/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.00% 0/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Nervous system disorders Lethargy	0.00% 0/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.25% 1/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Nervous system disorders Muscle Contractions Involuntary	0.25% 1/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.00% 0/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Nervous system disorders Paraesthesia	0.25% 1/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.00% 0/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Nervous system disorders Syncope	0.25% 1/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.25% 1/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Nervous system disorders Transient Global Amnesia	0.00% 0/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.25% 1/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Psychiatric disorders Confusional State	0.00% 0/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.25% 1/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Renal and urinary disorders Acute Kidney Injury	0.00% 0/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.74% 3/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Renal and urinary disorders Dysuria	0.00% 0/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.25% 1/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Renal and urinary disorders Hydronephrosis	0.00% 0/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.25% 1/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Renal and urinary disorders Renal Failure	0.00% 0/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.25% 1/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Reproductive system and breast disorders Female Genital Tract Fistula	0.00% 0/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.25% 1/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	0.25% 1/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.00% 0/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	0.00% 0/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.25% 1/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.2% 5/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.74% 3/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Respiratory, thoracic and mediastinal disorders Laryngospasm	0.25% 1/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.00% 0/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.74% 3/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.74% 3/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.25% 1/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.25% 1/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Respiratory, thoracic and mediastinal disorders Respiratory Distress	0.25% 1/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.00% 0/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.50% 2/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.00% 0/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Skin and subcutaneous tissue disorders Decubitus Ulcer	0.25% 1/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.00% 0/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Skin and subcutaneous tissue disorders Drug Eruption	0.25% 1/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.00% 0/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Skin and subcutaneous tissue disorders Rash	0.25% 1/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.00% 0/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Skin and subcutaneous tissue disorders Rash Macular	0.25% 1/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.00% 0/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Vascular disorders Superior Vena Cava Syndrome	0.25% 1/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	0.00% 0/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.

Other adverse events

Measure	Placebo n=404 participants at risk Participants received placebo tablet matched to rivaroxaban orally once daily for 180 days.	Rivaroxaban 10 mg n=405 participants at risk Participants received rivaroxaban 10 milligram (mg) tablet orally once daily for 180 days.
Blood and lymphatic system disorders Anaemia	14.6% 59/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	11.4% 46/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Blood and lymphatic system disorders Neutropenia	5.9% 24/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	6.2% 25/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Gastrointestinal disorders Constipation	3.0% 12/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	7.2% 29/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Gastrointestinal disorders Diarrhoea	8.9% 36/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	8.4% 34/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Gastrointestinal disorders Nausea	13.6% 55/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	13.6% 55/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Gastrointestinal disorders Vomiting	4.2% 17/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	6.9% 28/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
General disorders Fatigue	7.9% 32/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	10.9% 44/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.
Metabolism and nutrition disorders Decreased Appetite	6.2% 25/404 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.	5.2% 21/405 • Up to 32 weeks The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug. Deaths occurred throughout the study are reported below.

Additional Information

Clinical Leader

Janssen Scientific Affairs, LLC

Phone: 844-434-4210

Email: ClinicalTrialDisclosure@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
• Publication restrictions are in place

Restriction type: OTHER