Trial Outcomes & Findings for Apixaban or Dalteparin in Reducing Blood Clots in Patients With Cancer Related Venous Thromboembolism (NCT NCT02585713)

NCT ID: NCT02585713

Last Updated: 2020-08-04

Results Overview

The rate (percentage) of patients experiencing major bleeding at 6 months from treatment initiation and its associated 95% confidence interval was estimated separately by treatment arm using a cumulative incidence function, treating death without bleeding as a competing risk.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 300 participants
• Primary outcome timeframe: Up to 6 months
• Results posted on: 2020-08-04

Participant Flow

Participant milestones

Measure	Arm A (Apixaban) Patients receive apixaban 10 mg PO BID on days 1-7 and lower-dose apixaban 5 mg PO BID on days 8-180.	Arm B (Dalteparin) Patients receive dalteparin 200 IU/kg/day SC QD on days 1-30 and lower-dose dalteparin 150 IU/kg/day SC QD on days 31-180.
Overall Study STARTED	150	150
Overall Study COMPLETED	145	142
Overall Study NOT COMPLETED	5	8

Reasons for withdrawal

Measure	Arm A (Apixaban) Patients receive apixaban 10 mg PO BID on days 1-7 and lower-dose apixaban 5 mg PO BID on days 8-180.	Arm B (Dalteparin) Patients receive dalteparin 200 IU/kg/day SC QD on days 1-30 and lower-dose dalteparin 150 IU/kg/day SC QD on days 31-180.
Overall Study Withdrew prior to treatment	2	7
Overall Study Other	3	1

Baseline Characteristics

Apixaban or Dalteparin in Reducing Blood Clots in Patients With Cancer Related Venous Thromboembolism

Baseline characteristics by cohort

Measure	Arm A (Apixaban) n=150 Participants Patients receive apixaban 10 mg PO BID on days 1-7 and lower-dose apixaban 5 mg PO BID on days 8-180.	Arm B (Dalteparin) n=150 Participants Patients receive dalteparin 200 IU/kg/day SC QD on days 1-30 and lower-dose dalteparin 150 IU/kg/day SC QD on days 31-180.	Total n=300 Participants Total of all reporting groups
Age, Continuous	64.4 years STANDARD_DEVIATION 11.3 • n=5 Participants	64.0 years STANDARD_DEVIATION 10.8 • n=7 Participants	64.2 years STANDARD_DEVIATION 11.0 • n=5 Participants
Sex: Female, Male Female	78 Participants n=5 Participants	77 Participants n=7 Participants	155 Participants n=5 Participants
Sex: Female, Male Male	72 Participants n=5 Participants	73 Participants n=7 Participants	145 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	11 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) White	140 Participants n=5 Participants	138 Participants n=7 Participants	278 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
ECOG Performance Status 0	60 Participants n=5 Participants	62 Participants n=7 Participants	122 Participants n=5 Participants
ECOG Performance Status 1	70 Participants n=5 Participants	76 Participants n=7 Participants	146 Participants n=5 Participants
ECOG Performance Status 2	20 Participants n=5 Participants	12 Participants n=7 Participants	32 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 6 months

Population: Primary Analysis Population

The rate (percentage) of patients experiencing major bleeding at 6 months from treatment initiation and its associated 95% confidence interval was estimated separately by treatment arm using a cumulative incidence function, treating death without bleeding as a competing risk.

Outcome measures

Measure	Arm A (Apixaban) n=145 Participants Patients receive apixaban 10 mg PO BID on days 1-7 and lower-dose apixaban 5 mg PO BID on days 8-180.	Arm B (Dalteparin) n=142 Participants Patients receive dalteparin 200 IU/kg/day SC QD on days 1-30 and lower-dose dalteparin 150 IU/kg/day SC QD on days 31-180.
6 Month Bleeding Rate	0 percentage of patients Interval 0.0 to 0.0	2.1 percentage of patients Interval 0.6 to 6.6

SECONDARY outcome

Timeframe: Up to 6 months

A similar analysis as described for the primary safety analysis will be used. The rate (percentage) of patients experiencing major bleeding or a clinically relevant non-major bleed at 6 months from treatment initiation and its associated 95% confidence interval was estimated separately by treatment arm using a cumulative incidence function, treating death without bleeding as a competing risk.

Outcome measures

Measure	Arm A (Apixaban) n=145 Participants Patients receive apixaban 10 mg PO BID on days 1-7 and lower-dose apixaban 5 mg PO BID on days 8-180.	Arm B (Dalteparin) n=142 Participants Patients receive dalteparin 200 IU/kg/day SC QD on days 1-30 and lower-dose dalteparin 150 IU/kg/day SC QD on days 31-180.
Composite Bleeding Rate: Major Bleed or a Clinically Relevant Non-major Bleed	7.0 percentage of patients Interval 4.1 to 11.9	8.1 percentage of patients Interval 4.7 to 13.9

SECONDARY outcome

Timeframe: Up to 3 months post-treatment

Analyzed using the same methods described above for the primary endpoint.Time to the first event of the composite deep vein thrombosis (DVT)/pulmonary embolism (PE) is defined as the time from randomization to the date the patient experienced the first event of the composite deep vein thrombosis (DVT)/pulmonary embolism (PE).

Outcome measures

Measure	Arm A (Apixaban) n=149 Participants Patients receive apixaban 10 mg PO BID on days 1-7 and lower-dose apixaban 5 mg PO BID on days 8-180.	Arm B (Dalteparin) n=149 Participants Patients receive dalteparin 200 IU/kg/day SC QD on days 1-30 and lower-dose dalteparin 150 IU/kg/day SC QD on days 31-180.
Time to the First Event of the Composite Deep Vein Thrombosis (DVT)/Pulmonary Embolism (PE)	NA months The median and 95% CI was not reached due to limited number of events.	NA months The median and 95% CI was not reached due to limited number of events.

Adverse Events

Arm A (Apixaban)

Serious events: 62 serious events

Other events: 78 other events

Deaths: 35 deaths

Arm B (Dalteparin)

Serious events: 51 serious events

Other events: 71 other events

Deaths: 25 deaths

Serious adverse events

Measure	Arm A (Apixaban) n=148 participants at risk Patients receive apixaban 10 mg PO BID on days 1-7 and lower-dose apixaban 5 mg PO BID on days 8-180.	Arm B (Dalteparin) n=143 participants at risk Patients receive dalteparin 200 IU/kg/day SC QD on days 1-30 and lower-dose dalteparin 150 IU/kg/day SC QD on days 31-180.
Blood and lymphatic system disorders Anemia	2.0% 3/148 • Number of events 3 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	2.1% 3/143 • Number of events 3 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Blood and lymphatic system disorders Febrile neutropenia	0.68% 1/148 • Number of events 2 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	1.4% 2/143 • Number of events 2 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Cardiac disorders Acute coronary syndrome	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.00% 0/143 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Cardiac disorders Atrial flutter	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 2 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Cardiac disorders Heart failure	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Cardiac disorders Left ventricular systolic dysfunction	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.00% 0/143 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Cardiac disorders Pericardial effusion	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	1.4% 2/143 • Number of events 2 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Cardiac disorders Pericardial tamponade	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Gastrointestinal disorders Abdominal pain	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	2.8% 4/143 • Number of events 4 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Gastrointestinal disorders Ascites	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Gastrointestinal disorders Colitis	0.68% 1/148 • Number of events 2 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.00% 0/143 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Gastrointestinal disorders Colonic perforation	1.4% 2/148 • Number of events 2 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.00% 0/143 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Gastrointestinal disorders Constipation	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Gastrointestinal disorders Diarrhea	1.4% 2/148 • Number of events 2 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	2.1% 3/143 • Number of events 3 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Gastrointestinal disorders Duodenal obstruction	0.68% 1/148 • Number of events 2 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.00% 0/143 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Gastrointestinal disorders Dysphagia	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.00% 0/143 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Gastrointestinal disorders Enterocolitis	1.4% 2/148 • Number of events 3 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.00% 0/143 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Gastrointestinal disorders Esophageal obstruction	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 2 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Gastrointestinal disorders Gastric hemorrhage	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.00% 0/143 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Gastrointestinal disorders Mucositis oral	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Gastrointestinal disorders Nausea	1.4% 2/148 • Number of events 3 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	2.1% 3/143 • Number of events 3 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Gastrointestinal disorders Pancreatic necrosis	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Gastrointestinal disorders Retroperitoneal hemorrhage	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Gastrointestinal disorders Small intestinal obstruction	1.4% 2/148 • Number of events 2 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	1.4% 2/143 • Number of events 2 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.00% 0/143 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Gastrointestinal disorders Vomiting	1.4% 2/148 • Number of events 3 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	2.1% 3/143 • Number of events 3 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
General disorders Death NOS	2.0% 3/148 • Number of events 3 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
General disorders Edema face	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
General disorders Edema limbs	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	1.4% 2/143 • Number of events 3 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
General disorders Fatigue	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
General disorders Fever	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
General disorders Gait disturbance	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
General disorders General disorders and administration site conditions - Other, specify	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.00% 0/143 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
General disorders Non-cardiac chest pain	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Hepatobiliary disorders Cholecystitis	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Hepatobiliary disorders Hepatobiliary disorders - Other, specify	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 2 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Immune system disorders Immune system disorders - Other, specify	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Infections and infestations Abdominal infection	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Infections and infestations Appendicitis	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.00% 0/143 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Infections and infestations Esophageal infection	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.00% 0/143 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Infections and infestations Hepatic infection	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Infections and infestations Infections and infestations - Other, specify	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	2.1% 3/143 • Number of events 4 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Infections and infestations Lung infection	3.4% 5/148 • Number of events 5 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	2.1% 3/143 • Number of events 4 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Infections and infestations Sepsis	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	3.5% 5/143 • Number of events 6 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Infections and infestations Skin infection	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Infections and infestations Urinary tract infection	2.7% 4/148 • Number of events 4 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Injury, poisoning and procedural complications Fall	2.0% 3/148 • Number of events 3 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.00% 0/143 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Injury, poisoning and procedural complications Fracture	2.0% 3/148 • Number of events 3 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 2 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Investigations Alanine aminotransferase increased	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 2 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Investigations Aspartate aminotransferase increased	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 2 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Investigations Cardiac troponin I increased	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.00% 0/143 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Investigations Creatinine increased	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	2.1% 3/143 • Number of events 3 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Investigations INR increased	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Investigations Lymphocyte count decreased	1.4% 2/148 • Number of events 2 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 3 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Investigations Neutrophil count decreased	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.00% 0/143 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Investigations Platelet count decreased	2.0% 3/148 • Number of events 3 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Investigations Weight gain	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Investigations White blood cell decreased	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Metabolism and nutrition disorders Anorexia	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Metabolism and nutrition disorders Dehydration	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	1.4% 2/143 • Number of events 2 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 2 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Metabolism and nutrition disorders Hyperkalemia	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.00% 0/143 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Metabolism and nutrition disorders Hyperuricemia	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Metabolism and nutrition disorders Hypoalbuminemia	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	1.4% 2/143 • Number of events 2 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Metabolism and nutrition disorders Hyponatremia	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	1.4% 2/143 • Number of events 4 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Musculoskeletal and connective tissue disorders Back pain	1.4% 2/148 • Number of events 2 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Musculoskeletal and connective tissue disorders Flank pain	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Musculoskeletal and connective tissue disorders Osteonecrosis of jaw	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.00% 0/143 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	21.6% 32/148 • Number of events 35 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	16.8% 24/143 • Number of events 26 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Nervous system disorders Cognitive disturbance	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Nervous system disorders Dysarthria	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.00% 0/143 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Nervous system disorders Headache	2.0% 3/148 • Number of events 3 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.00% 0/143 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Nervous system disorders Somnolence	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.00% 0/143 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Nervous system disorders Stroke	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Nervous system disorders Syncope	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Psychiatric disorders Anxiety	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.00% 0/143 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Psychiatric disorders Depression	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.00% 0/143 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Renal and urinary disorders Acute kidney injury	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	1.4% 2/143 • Number of events 2 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Renal and urinary disorders Chronic kidney disease	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	1.4% 2/143 • Number of events 2 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Reproductive system and breast disorders Fallopian tube obstruction	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Respiratory, thoracic and mediastinal disorders Aspiration	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.00% 0/143 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.00% 0/143 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Respiratory, thoracic and mediastinal disorders Hypoxia	1.4% 2/148 • Number of events 2 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.00% 0/143 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 2 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Respiratory, thoracic and mediastinal disorders Pneumonitis	1.4% 2/148 • Number of events 2 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.00% 0/143 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.4% 2/148 • Number of events 2 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Surgical and medical procedures Surgical and medical procedures - Other, specify	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Vascular disorders Bleeding	1.4% 2/148 • Number of events 2 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	4.9% 7/143 • Number of events 7 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Vascular disorders Hematoma	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Vascular disorders Hypertension	1.4% 2/148 • Number of events 3 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.00% 0/143 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Vascular disorders Hypotension	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Vascular disorders Thromboembolic event	0.68% 1/148 • Number of events 2 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	2.8% 4/143 • Number of events 4 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.

Other adverse events

Measure	Arm A (Apixaban) n=148 participants at risk Patients receive apixaban 10 mg PO BID on days 1-7 and lower-dose apixaban 5 mg PO BID on days 8-180.	Arm B (Dalteparin) n=143 participants at risk Patients receive dalteparin 200 IU/kg/day SC QD on days 1-30 and lower-dose dalteparin 150 IU/kg/day SC QD on days 31-180.
Blood and lymphatic system disorders Anemia	9.5% 14/148 • Number of events 28 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	8.4% 12/143 • Number of events 22 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	1.4% 2/143 • Number of events 2 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Cardiac disorders Cardiac disorders - Other, specify	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Cardiac disorders Chest pain - cardiac	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.00% 0/143 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Cardiac disorders Conduction disorder	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Cardiac disorders Pericardial effusion	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Cardiac disorders Ventricular tachycardia	0.68% 1/148 • Number of events 4 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.00% 0/143 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Endocrine disorders Hypothyroidism	1.4% 2/148 • Number of events 2 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Eye disorders Conjunctivitis	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Eye disorders Retinal vascular disorder	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 2 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Gastrointestinal disorders Abdominal distension	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Gastrointestinal disorders Abdominal pain	1.4% 2/148 • Number of events 2 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.00% 0/143 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Gastrointestinal disorders Ascites	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Gastrointestinal disorders Colonic obstruction	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.00% 0/143 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Gastrointestinal disorders Constipation	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.00% 0/143 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Gastrointestinal disorders Diarrhea	2.7% 4/148 • Number of events 6 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	2.1% 3/143 • Number of events 3 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Gastrointestinal disorders Enterocolitis	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.00% 0/143 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Gastrointestinal disorders Gastroesophageal reflux disease	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.00% 0/143 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Gastrointestinal disorders Mucositis oral	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	1.4% 2/143 • Number of events 2 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Gastrointestinal disorders Nausea	2.7% 4/148 • Number of events 4 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	2.1% 3/143 • Number of events 3 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Gastrointestinal disorders Vomiting	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	2.1% 3/143 • Number of events 3 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
General disorders Edema limbs	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
General disorders Fatigue	1.4% 2/148 • Number of events 2 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
General disorders Injection site reaction	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	20.3% 29/143 • Number of events 70 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
General disorders Pain	1.4% 2/148 • Number of events 2 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Infections and infestations Abdominal infection	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.00% 0/143 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Infections and infestations Bone infection	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.00% 0/143 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Infections and infestations Bronchial infection	0.68% 1/148 • Number of events 2 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.00% 0/143 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Infections and infestations Conjunctivitis infective	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Infections and infestations Enterocolitis infectious	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Infections and infestations Infections and infestations - Other, specify	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Infections and infestations Lung infection	1.4% 2/148 • Number of events 2 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.00% 0/143 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Infections and infestations Mucosal infection	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	1.4% 2/143 • Number of events 2 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Infections and infestations Papulopustular rash	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Infections and infestations Sepsis	1.4% 2/148 • Number of events 2 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.00% 0/143 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Infections and infestations Urinary tract infection	1.4% 2/148 • Number of events 2 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	1.4% 2/143 • Number of events 2 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Injury, poisoning and procedural complications Bruising	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	1.4% 2/143 • Number of events 2 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Investigations Alanine aminotransferase increased	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	1.4% 2/143 • Number of events 2 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Investigations Alkaline phosphatase increased	2.0% 3/148 • Number of events 4 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	1.4% 2/143 • Number of events 2 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Investigations Aspartate aminotransferase increased	2.0% 3/148 • Number of events 3 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Investigations Blood bilirubin increased	1.4% 2/148 • Number of events 2 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	1.4% 2/143 • Number of events 3 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Investigations Cardiac troponin I increased	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.00% 0/143 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Investigations Creatinine increased	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	1.4% 2/143 • Number of events 2 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Investigations INR increased	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Investigations Lymphocyte count decreased	6.1% 9/148 • Number of events 18 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	5.6% 8/143 • Number of events 13 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Investigations Lymphocyte count increased	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Investigations Neutrophil count decreased	6.8% 10/148 • Number of events 16 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	4.9% 7/143 • Number of events 23 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Investigations Platelet count decreased	27.0% 40/148 • Number of events 93 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	18.2% 26/143 • Number of events 71 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Investigations Weight gain	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.00% 0/143 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Investigations Weight loss	1.4% 2/148 • Number of events 3 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Investigations White blood cell decreased	4.7% 7/148 • Number of events 16 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	4.9% 7/143 • Number of events 21 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Metabolism and nutrition disorders Anorexia	2.0% 3/148 • Number of events 3 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Metabolism and nutrition disorders Dehydration	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.00% 0/143 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Metabolism and nutrition disorders Hypercalcemia	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.00% 0/143 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Metabolism and nutrition disorders Hyperglycemia	0.68% 1/148 • Number of events 2 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Metabolism and nutrition disorders Hypoalbuminemia	2.0% 3/148 • Number of events 3 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	2.1% 3/143 • Number of events 3 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Metabolism and nutrition disorders Hypocalcemia	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	1.4% 2/143 • Number of events 3 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Metabolism and nutrition disorders Hypokalemia	1.4% 2/148 • Number of events 4 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	2.8% 4/143 • Number of events 7 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Metabolism and nutrition disorders Hypomagnesemia	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.00% 0/143 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	2.1% 3/143 • Number of events 3 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Metabolism and nutrition disorders Hypophosphatemia	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Musculoskeletal and connective tissue disorders Arthralgia	0.68% 1/148 • Number of events 2 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.00% 0/143 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Musculoskeletal and connective tissue disorders Back pain	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 2 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	1.4% 2/148 • Number of events 3 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	1.4% 2/143 • Number of events 3 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.00% 0/143 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Musculoskeletal and connective tissue disorders Myalgia	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Nervous system disorders Depressed level of consciousness	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.00% 0/143 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Nervous system disorders Encephalopathy	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.00% 0/143 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Nervous system disorders Headache	2.0% 3/148 • Number of events 3 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.00% 0/143 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Nervous system disorders Peripheral sensory neuropathy	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Nervous system disorders Somnolence	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.00% 0/143 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Nervous system disorders Syncope	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.00% 0/143 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Psychiatric disorders Anxiety	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Psychiatric disorders Confusion	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Psychiatric disorders Insomnia	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Renal and urinary disorders Chronic kidney disease	1.4% 2/148 • Number of events 5 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.00% 0/143 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Renal and urinary disorders Urinary retention	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	1.4% 2/143 • Number of events 2 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Reproductive system and breast disorders Reproductive system and breast disorders - Other, specify	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Respiratory, thoracic and mediastinal disorders Adult respiratory distress syndrome	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.00% 0/143 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Respiratory, thoracic and mediastinal disorders Cough	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Respiratory, thoracic and mediastinal disorders Dyspnea	2.0% 3/148 • Number of events 3 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	1.4% 2/143 • Number of events 2 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Respiratory, thoracic and mediastinal disorders Wheezing	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.00% 0/143 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Skin and subcutaneous tissue disorders Pruritus	0.68% 1/148 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.70% 1/143 • Number of events 1 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Vascular disorders Bleeding	20.9% 31/148 • Number of events 38 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	16.1% 23/143 • Number of events 27 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Vascular disorders Hypertension	3.4% 5/148 • Number of events 9 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	1.4% 2/143 • Number of events 3 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Vascular disorders Hypotension	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	1.4% 2/143 • Number of events 2 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Vascular disorders Thromboembolic event	0.00% 0/148 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	1.4% 2/143 • Number of events 2 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.
Vascular disorders Vascular disorders - Other, specify	1.4% 2/148 • Number of events 3 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.	0.00% 0/143 • Up to 3 months after completion of treatment Adverse events are summarized below for patients who received at least one cycle of treatment (i.e. patients who completed the study and patients with unknown reason for not completing the study in the Participant Flow) and completed at least one adverse event form.

Additional Information

Robert D. McBane, M.D.

Mayo Clinic

Phone: 507/284-4565

Email: Mcbane.robert@mayo.edu

Results disclosure agreements

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