Trial Outcomes & Findings for Carfilzomib for the Treatment of Patients With Advanced Neuroendocrine Cancers (NCT NCT02318784)

Last Updated: 2023-12-05

Results Overview

Percentage of participants with confirmed complete response (CR) or partial response (PR) (i.e. 2 CRs or PRs at least 4 weeks apart) to treatment according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) CR=disappearance of all target lesions. PR=at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

62 participants

Primary outcome timeframe

every 3 cycles (1 cycle= 28 days) until treatment discontinuation up to 4 years

Results posted on

2023-12-05

Participant Flow

Participant milestones

Participant milestones
Measure	Carfilzomib Carfilzomib - administered as an intravenous (IV) infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. Cycle 1: First two doses of Carfilzomib 20 mg/m\^2 IV; subsequent doses at 56 mg/m2 IV Cycle 2 onwards: Carfilzomib 56 mg/m\^2 IV
Overall Study STARTED	62
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	62

Reasons for withdrawal

Reasons for withdrawal
Measure	Carfilzomib Carfilzomib - administered as an intravenous (IV) infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. Cycle 1: First two doses of Carfilzomib 20 mg/m\^2 IV; subsequent doses at 56 mg/m2 IV Cycle 2 onwards: Carfilzomib 56 mg/m\^2 IV
Overall Study Adverse Event	13
Overall Study Death	2
Overall Study Progressive Disease	37
Overall Study Withdrawal by Subject	10

Baseline Characteristics

Carfilzomib for the Treatment of Patients With Advanced Neuroendocrine Cancers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Carfilzomib n=62 Participants Carfilzomib - administered as an intravenous (IV) infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. Cycle 1: First two doses of Carfilzomib 20 mg/m\^2 IV; subsequent doses at 56 mg/m2 IV Cycle 2 onwards: Carfilzomib 56 mg/m\^2 IV
Age, Continuous	63 years n=93 Participants
Sex: Female, Male Female	37 Participants n=93 Participants
Sex: Female, Male Male	25 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	8 Participants n=93 Participants
Race (NIH/OMB) White	54 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	62 Participants n=93 Participants

PRIMARY outcome

Timeframe: every 3 cycles (1 cycle= 28 days) until treatment discontinuation up to 4 years

Population: All enrolled patients who received at least one full or partial dose of the study drug and who had measurable disease at baseline were included in the analysis.

Outcome measures

Outcome measures
Measure	Carfilzomib n=62 Participants Carfilzomib - administered as an intravenous (IV) infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. Cycle 1: First two doses of Carfilzomib 20 mg/m\^2 IV; subsequent doses at 56 mg/m2 IV Cycle 2 onwards: Carfilzomib 56 mg/m\^2 IV
Overall Response Rate (ORR)	3.226 percentage of participants Interval 0.4 to 11.2

SECONDARY outcome

Timeframe: every 3 cycles (1 cycle= 28 days) until treatment discontinuation up to 4 years

Population: All enrolled patients who received at least one full or partial dose of the study drug and who had measurable disease at baseline were included in the analysis.

Percentage of participants with complete response (CR), partial response (PR), or stable disease (SD) (≥ 6 cycles) according to RECIST v1.1 criteria. Complete Response is defined per RECIST as the disappearance of all target/non-target lesions and normalization of tumor markers. Partial Response is defined per RECIST as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Stable disease is defined per RECIST as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest (nadir) sum LD since the treatment started.

Outcome measures

Outcome measures
Measure	Carfilzomib n=62 Participants Carfilzomib - administered as an intravenous (IV) infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. Cycle 1: First two doses of Carfilzomib 20 mg/m\^2 IV; subsequent doses at 56 mg/m2 IV Cycle 2 onwards: Carfilzomib 56 mg/m\^2 IV
Disease Control Rate (DCR)	58 percentage of participants Interval 44.8 to 70.5

SECONDARY outcome

Timeframe: up to 4 years

Population: All enrolled patients who received at least one full or partial dose of the study drug and who had measurable disease at baseline were included in the analysis.

Measured from Day 1 of study drug administration to disease progression as defined by RECIST v1.1, or death on the study. Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or unequivocal progression of non-target lesions or the appearance of one or more new lesions. Patients who did not have disease progression or death documented were censored on the date of the last visit with adequate assessment.

Outcome measures

Outcome measures
Measure	Carfilzomib n=62 Participants Carfilzomib - administered as an intravenous (IV) infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. Cycle 1: First two doses of Carfilzomib 20 mg/m\^2 IV; subsequent doses at 56 mg/m2 IV Cycle 2 onwards: Carfilzomib 56 mg/m\^2 IV
Progression Free Survival (PFS)	8 months Interval 2.9 to 11.1

SECONDARY outcome

Timeframe: From the day of the first dose to 30 days after the last dose of study medication, up to 4 years

Population: All enrolled patients who received at least one full or partial dose of the study drug.

The number of treatment-emergent adverse events will be graded utilizing the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03

Outcome measures

Outcome measures
Measure	Carfilzomib n=62 Participants Carfilzomib - administered as an intravenous (IV) infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. Cycle 1: First two doses of Carfilzomib 20 mg/m\^2 IV; subsequent doses at 56 mg/m2 IV Cycle 2 onwards: Carfilzomib 56 mg/m\^2 IV
Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability	56 Participants

Adverse Events

Carfilzomib

Serious events: 31 serious events

Other events: 61 other events

Deaths: 10 deaths

Serious adverse events

Serious adverse events
Measure	Carfilzomib n=62 participants at risk Carfilzomib - administered as an intravenous (IV) infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. Cycle 1: First two doses of Carfilzomib 20 mg/m\^2 IV; subsequent doses at 56 mg/m2 IV Cycle 2 onwards: Carfilzomib 56 mg/m\^2 IV
Blood and lymphatic system disorders Anaemia	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Blood and lymphatic system disorders Thrombocytopenia	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Blood and lymphatic system disorders Thrombotic thrombocytopenic purpura	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Cardiac disorders Acute left ventricular failure	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Cardiac disorders Cardiac arrest	3.2% 2/62 • Number of events 2 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Cardiac disorders Cardiac failure acute	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Cardiac disorders Cardiac failure congestive	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Endocrine disorders Ectopic ACTH syndrome	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Abdominal pain	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Colitis	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Diarrhoea	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Nausea	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Small intestinal obstruction	3.2% 2/62 • Number of events 3 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Vomiting	3.2% 2/62 • Number of events 2 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
General disorders Asthenia	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
General disorders Chest pain	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
General disorders Pyrexia	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Hepatobiliary disorders Cholangitis	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Infections and infestations Bacteraemia	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Infections and infestations Cellulitis	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Infections and infestations Enteritis infectious	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Infections and infestations Kidney infection	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Infections and infestations Pyelonephritis	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Infections and infestations Sepsis	3.2% 2/62 • Number of events 2 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Infections and infestations Staphylococcal bacteraemia	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Infections and infestations Urinary tract infection	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Infections and infestations Wound infection	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Injury, poisoning and procedural complications Subdural haematoma	1.6% 1/62 • Number of events 2 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Metabolism and nutrition disorders Dehydration	4.8% 3/62 • Number of events 8 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Metabolism and nutrition disorders Failure to thrive	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Musculoskeletal and connective tissue disorders Back pain	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Musculoskeletal and connective tissue disorders Muscular weakness	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Nervous system disorders Cerebrovascular accident	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Nervous system disorders Cognitive disorder	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Nervous system disorders Haemorrhagic transformation stroke	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Nervous system disorders Metabolic encephalopathy	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Nervous system disorders Syncope	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Psychiatric disorders Confusional state	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Psychiatric disorders Mental status changes	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Renal and urinary disorders Nephrolithiasis	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Renal and urinary disorders Renal failure	3.2% 2/62 • Number of events 2 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Respiratory, thoracic and mediastinal disorders Pneumonitis	3.2% 2/62 • Number of events 2 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Vascular disorders Deep vein thrombosis	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Vascular disorders Hypertension	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Vascular disorders Malignant hypertension	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
General disorders Ticuspid valve replacement	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

Other adverse events

Other adverse events
Measure	Carfilzomib n=62 participants at risk Carfilzomib - administered as an intravenous (IV) infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. Cycle 1: First two doses of Carfilzomib 20 mg/m\^2 IV; subsequent doses at 56 mg/m2 IV Cycle 2 onwards: Carfilzomib 56 mg/m\^2 IV
Blood and lymphatic system disorders Anaemia	19.4% 12/62 • Number of events 41 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Blood and lymphatic system disorders Increased tendency to bruise	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Blood and lymphatic system disorders Leukocytosis	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Blood and lymphatic system disorders Lymphadenopathy	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Blood and lymphatic system disorders Neutropenia	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Blood and lymphatic system disorders Thrombocytopenia	17.7% 11/62 • Number of events 89 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Cardiac disorders Acute left ventricular failure	3.2% 2/62 • Number of events 2 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Cardiac disorders Atrial fibrillation	3.2% 2/62 • Number of events 2 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Cardiac disorders Palpitations	3.2% 2/62 • Number of events 2 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Ear and labyrinth disorders Ear pruritus	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Endocrine disorders Ectopic ACTH syndrome	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Endocrine disorders Hyperthyroidism	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Eye disorders Blepharitis	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Eye disorders Cataract	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Eye disorders Conjunctival haemorrhage	3.2% 2/62 • Number of events 3 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Eye disorders Diplopia	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Eye disorders Eye haematoma	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Eye disorders Eye swelling	1.6% 1/62 • Number of events 2 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Eye disorders Lacrimation increased	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Eye disorders Periorbital oedema	3.2% 2/62 • Number of events 4 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Eye disorders Vision blurred	6.5% 4/62 • Number of events 4 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Abdominal discomfort	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Abdominal distension	16.1% 10/62 • Number of events 15 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Abdominal pain	17.7% 11/62 • Number of events 19 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Abdominal pain upper	9.7% 6/62 • Number of events 6 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Abdominal rigidity	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Barrett's oesophagus	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Constipation	17.7% 11/62 • Number of events 15 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Defaecation urgency	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Diarrhoea	41.9% 26/62 • Number of events 70 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Discoloured vomit	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Dry mouth	9.7% 6/62 • Number of events 6 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Dyspepsia	6.5% 4/62 • Number of events 4 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Dysphagia	3.2% 2/62 • Number of events 3 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Enteritis	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Eructation	3.2% 2/62 • Number of events 2 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Flatulence	12.9% 8/62 • Number of events 10 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Gastritis	3.2% 2/62 • Number of events 2 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Gastrointestinal haemorrhage	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Gastrooesophageal reflux disease	6.5% 4/62 • Number of events 4 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Gingival bleeding	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Haematochezia	3.2% 2/62 • Number of events 2 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Haemorrhoids	3.2% 2/62 • Number of events 2 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Nausea	59.7% 37/62 • Number of events 74 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Pancreatic cyst	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Pancreatic failure	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Proctalgia	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Rectal haemorrhage	3.2% 2/62 • Number of events 2 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Retching	4.8% 3/62 • Number of events 4 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Stomatitis	3.2% 2/62 • Number of events 3 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Toothache	3.2% 2/62 • Number of events 2 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Vomiting	51.6% 32/62 • Number of events 66 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
General disorders Asthenia	16.1% 10/62 • Number of events 14 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
General disorders Catheter site bruise	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
General disorders Catheter site inflammation	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
General disorders Catheter site pain	4.8% 3/62 • Number of events 3 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
General disorders Catheter site related reaction	3.2% 2/62 • Number of events 2 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
General disorders Chest pain	6.5% 4/62 • Number of events 4 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
General disorders Chills	19.4% 12/62 • Number of events 29 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
General disorders Early satiety	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
General disorders Fatigue	53.2% 33/62 • Number of events 65 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
General disorders Feeling hot	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
General disorders Gait disturbance	1.6% 1/62 • Number of events 2 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
General disorders Generalised oedema	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
General disorders Influenza like illness	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
General disorders Infusion site pain	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
General disorders Localised oedema	3.2% 2/62 • Number of events 2 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
General disorders Malaise	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
General disorders Non-cardiac chest pain	3.2% 2/62 • Number of events 2 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
General disorders Oedema	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
General disorders Oedema peripheral	32.3% 20/62 • Number of events 33 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
General disorders Pain	11.3% 7/62 • Number of events 8 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
General disorders Peripheral swelling	6.5% 4/62 • Number of events 4 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
General disorders Pyrexia	29.0% 18/62 • Number of events 35 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
General disorders Thirst	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Immune system disorders Hypersensitivity	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Infections and infestations Bronchitis	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Infections and infestations Cellulitis	8.1% 5/62 • Number of events 7 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Infections and infestations Chronic sinusitis	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Infections and infestations Clostridium difficile infection	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Infections and infestations Conjunctivitis	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Infections and infestations Conjunctivitis viral	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Infections and infestations Device related infection	1.6% 1/62 • Number of events 2 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Infections and infestations Ear infection	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Infections and infestations Eye infection	1.6% 1/62 • Number of events 2 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Infections and infestations Eye infection viral	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Infections and infestations Fungal infection	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Infections and infestations Herpes zoster	3.2% 2/62 • Number of events 2 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Infections and infestations Influenza	3.2% 2/62 • Number of events 2 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Infections and infestations Oral candidiasis	4.8% 3/62 • Number of events 3 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Infections and infestations Oral herpes	4.8% 3/62 • Number of events 3 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Infections and infestations Perirectal abscess	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Infections and infestations Pharyngitis streptococcal	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Infections and infestations Pneumonia	3.2% 2/62 • Number of events 4 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Infections and infestations Sepsis	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Infections and infestations Sinusitis	6.5% 4/62 • Number of events 4 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Infections and infestations Upper respiratory tract infection	12.9% 8/62 • Number of events 15 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Infections and infestations Urinary tract infection	6.5% 4/62 • Number of events 12 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Infections and infestations Wound infection	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Injury, poisoning and procedural complications Burns second degree	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Injury, poisoning and procedural complications Contusion	3.2% 2/62 • Number of events 4 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Injury, poisoning and procedural complications Facial bones fracture	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Injury, poisoning and procedural complications Fall	1.6% 1/62 • Number of events 2 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Injury, poisoning and procedural complications Infusion related reaction	4.8% 3/62 • Number of events 3 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Injury, poisoning and procedural complications Muscle strain	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Injury, poisoning and procedural complications Tooth fracture	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Injury, poisoning and procedural complications Wound	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Investigations Alanine aminotransferase	1.6% 1/62 • Number of events 2 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Investigations Alanine aminotransferase increased	9.7% 6/62 • Number of events 11 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Investigations Ammonia increased	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Investigations Aspartate aminotransferase increased	9.7% 6/62 • Number of events 15 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Investigations Blood alkaline phosphatase increased	9.7% 6/62 • Number of events 19 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Investigations Blood bilirubin increased	9.7% 6/62 • Number of events 19 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Investigations Blood calcium increased	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Investigations Blood creatine increased	3.2% 2/62 • Number of events 2 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Investigations Blood creatinine increased	12.9% 8/62 • Number of events 22 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Investigations Blood glucose increased	3.2% 2/62 • Number of events 3 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Investigations Blood potassium decreased	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Investigations Blood pressure increased	3.2% 2/62 • Number of events 6 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Investigations Body temperature increased	1.6% 1/62 • Number of events 2 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Investigations Brain natriuretic peptide increased	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Investigations Cardiac murmur	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Investigations Creatinine renal clearance decreased	3.2% 2/62 • Number of events 3 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Investigations Creatinine renal clearance increased	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Investigations Ejection fraction decreased	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Investigations Glomerular filtration rate decreased	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Investigations Haemoglobin decreased	3.2% 2/62 • Number of events 5 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Investigations Neutrophil count decreased	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Investigations Platelet count	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Investigations Platelet count decreased	14.5% 9/62 • Number of events 72 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Investigations Protein total decreased	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Investigations Respiratory rate increased	1.6% 1/62 • Number of events 2 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Investigations Staphylococcus test positive	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Investigations Transferrin saturation decreased	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Investigations Urine bilirubin increased	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Investigations Weight decreased	14.5% 9/62 • Number of events 15 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Investigations Weight increased	3.2% 2/62 • Number of events 2 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Investigations White blood cell count increased	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Metabolism and nutrition disorders Decreased appetite	19.4% 12/62 • Number of events 17 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Metabolism and nutrition disorders Dehydration	16.1% 10/62 • Number of events 21 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Metabolism and nutrition disorders Fluid retention	3.2% 2/62 • Number of events 2 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Metabolism and nutrition disorders Hypercholesterolaemia	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Metabolism and nutrition disorders Hyperglycaemia	8.1% 5/62 • Number of events 8 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Metabolism and nutrition disorders Hyperkalaemia	3.2% 2/62 • Number of events 5 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Metabolism and nutrition disorders Hypernatraemia	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Metabolism and nutrition disorders Hypoalbuminaemia	3.2% 2/62 • Number of events 5 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Metabolism and nutrition disorders Hypocalcaemia	4.8% 3/62 • Number of events 6 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Metabolism and nutrition disorders Hypoglycaemia	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Metabolism and nutrition disorders Hypokalaemia	9.7% 6/62 • Number of events 10 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Metabolism and nutrition disorders Hypomagnesaemia	4.8% 3/62 • Number of events 3 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Metabolism and nutrition disorders Hypovolaemia	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Metabolism and nutrition disorders Iron deficiency	4.8% 3/62 • Number of events 3 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Metabolism and nutrition disorders Vitamin B12 deficiency	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Musculoskeletal and connective tissue disorders Arthralgia	11.3% 7/62 • Number of events 10 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Musculoskeletal and connective tissue disorders Back pain	17.7% 11/62 • Number of events 21 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Musculoskeletal and connective tissue disorders Flank pain	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Musculoskeletal and connective tissue disorders Joint swelling	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Musculoskeletal and connective tissue disorders Muscle spasms	6.5% 4/62 • Number of events 9 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Musculoskeletal and connective tissue disorders Muscle tightness	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Musculoskeletal and connective tissue disorders Muscular weakness	6.5% 4/62 • Number of events 5 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	3.2% 2/62 • Number of events 4 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	3.2% 2/62 • Number of events 2 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Musculoskeletal and connective tissue disorders Myalgia	6.5% 4/62 • Number of events 4 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Musculoskeletal and connective tissue disorders Neck pain	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Musculoskeletal and connective tissue disorders Osteoarthritis	1.6% 1/62 • Number of events 2 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Musculoskeletal and connective tissue disorders Pain in extremity	9.7% 6/62 • Number of events 9 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Seborrhoeic keratosis	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Nervous system disorders Amnesia	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Nervous system disorders Cognitive disorder	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Nervous system disorders Dizziness	22.6% 14/62 • Number of events 14 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Nervous system disorders Dysgeusia	1.6% 1/62 • Number of events 2 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Nervous system disorders Headache	41.9% 26/62 • Number of events 41 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Nervous system disorders Hypersomnia	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Nervous system disorders Hypoaesthesia	4.8% 3/62 • Number of events 3 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Nervous system disorders Lethargy	3.2% 2/62 • Number of events 3 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Nervous system disorders Memory impairment	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Nervous system disorders Migraine	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Nervous system disorders Neuropathy peripheral	3.2% 2/62 • Number of events 2 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Nervous system disorders Paraesthesia	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Nervous system disorders Peripheral sensory neuropathy	3.2% 2/62 • Number of events 2 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Nervous system disorders Presyncope	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Nervous system disorders Seizure	3.2% 2/62 • Number of events 2 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Nervous system disorders Somnolence	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Nervous system disorders Taste disorder	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Psychiatric disorders Abnormal dreams	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Psychiatric disorders Anxiety	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Psychiatric disorders Confusional state	3.2% 2/62 • Number of events 2 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Psychiatric disorders Delirium	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Psychiatric disorders Depression	6.5% 4/62 • Number of events 4 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Psychiatric disorders Insomnia	22.6% 14/62 • Number of events 21 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Psychiatric disorders Irritability	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Psychiatric disorders Mental status changes	3.2% 2/62 • Number of events 4 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Renal and urinary disorders Acute kidney injury	4.8% 3/62 • Number of events 3 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Renal and urinary disorders Chromaturia	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Renal and urinary disorders Chronic kidney disease	1.6% 1/62 • Number of events 7 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Renal and urinary disorders Dysuria	4.8% 3/62 • Number of events 3 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Renal and urinary disorders Nephrolithiasis	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Renal and urinary disorders Proteinuria	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Renal and urinary disorders Renal impairment	3.2% 2/62 • Number of events 3 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Renal and urinary disorders Urinary incontinence	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Renal and urinary disorders Urinary retention	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Renal and urinary disorders Urinary tract pain	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Reproductive system and breast disorders Oedema genital	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Reproductive system and breast disorders Vaginal haemorrhage	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	1.6% 1/62 • Number of events 2 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Respiratory, thoracic and mediastinal disorders Cough	19.4% 12/62 • Number of events 21 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Respiratory, thoracic and mediastinal disorders Dysphonia	3.2% 2/62 • Number of events 2 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Respiratory, thoracic and mediastinal disorders Dyspnoea	25.8% 16/62 • Number of events 26 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	3.2% 2/62 • Number of events 2 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Respiratory, thoracic and mediastinal disorders Dyspnoea paroxysmal nocturnal	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Respiratory, thoracic and mediastinal disorders Hypoxia	4.8% 3/62 • Number of events 3 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Respiratory, thoracic and mediastinal disorders Lower respiratory tract congestion	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Respiratory, thoracic and mediastinal disorders Nasal congestion	6.5% 4/62 • Number of events 4 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	4.8% 3/62 • Number of events 3 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Respiratory, thoracic and mediastinal disorders Paranasal sinus hypersecretion	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Respiratory, thoracic and mediastinal disorders Pneumonitis	3.2% 2/62 • Number of events 2 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Respiratory, thoracic and mediastinal disorders Productive cough	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	4.8% 3/62 • Number of events 4 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	3.2% 2/62 • Number of events 3 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Respiratory, thoracic and mediastinal disorders Throat irritation	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract congestion	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	1.6% 1/62 • Number of events 4 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Respiratory, thoracic and mediastinal disorders Wheezing	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Skin and subcutaneous tissue disorders Alopecia	4.8% 3/62 • Number of events 3 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Skin and subcutaneous tissue disorders Ecchymosis	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Skin and subcutaneous tissue disorders Erythema	3.2% 2/62 • Number of events 4 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Skin and subcutaneous tissue disorders Hair colour changes	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Skin and subcutaneous tissue disorders Hyperhidrosis	6.5% 4/62 • Number of events 4 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Skin and subcutaneous tissue disorders Night sweats	9.7% 6/62 • Number of events 7 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Skin and subcutaneous tissue disorders Petechiae	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Skin and subcutaneous tissue disorders Precancerous skin lesion	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Skin and subcutaneous tissue disorders Pruritus	3.2% 2/62 • Number of events 5 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Skin and subcutaneous tissue disorders Rash	8.1% 5/62 • Number of events 6 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Skin and subcutaneous tissue disorders Rash macular	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Skin and subcutaneous tissue disorders Rash maculo-papular	6.5% 4/62 • Number of events 5 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Skin and subcutaneous tissue disorders Rash pruritic	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	1.6% 1/62 • Number of events 3 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Skin and subcutaneous tissue disorders Skin irritation	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Skin and subcutaneous tissue disorders Skin lesion	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Skin and subcutaneous tissue disorders Skin ulcer	3.2% 2/62 • Number of events 2 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Skin and subcutaneous tissue disorders Urticaria	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Surgical and medical procedures Skin neoplasm excision	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Vascular disorders Embolism	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Vascular disorders Flushing	6.5% 4/62 • Number of events 4 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Vascular disorders Hot flush	6.5% 4/62 • Number of events 5 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Vascular disorders Hypertension	25.8% 16/62 • Number of events 21 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Vascular disorders Hypotension	11.3% 7/62 • Number of events 7 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Vascular disorders Pallor	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Vascular disorders Phlebitis	1.6% 1/62 • Number of events 1 • From the day of the first dose to 30 days after the last dose of study medication, up to 4 years All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

Additional Information

Sarah Cannon Development Innovations, LLC

Phone: 844-710-6157

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60