Trial Outcomes & Findings for Phase II Trial Of Gemcitabine Plus Nab-Paclitaxel +/- OGX-427 In Patients With Metastatic Pancreatic Cancer (NCT NCT01844817)

NCT ID: NCT01844817

Last Updated: 2017-05-16

Results Overview

Overall survival defined as the time, in months, from date of randomization until date of death or date last known alive whichever comes first, assessed up to 2 years.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 132 participants
• Primary outcome timeframe: Up to 2 years
• Results posted on: 2017-05-16

Participant Flow

Between September 2013 and December 2014, 132 subjhects with untreated metastatic pancreatic cancer were enrolled in the trial from 11 U.S. investigational sites.

Subjects were enrolled and randomized in a 1:1 ratio (66 per Arm) to receive a combination of gemcitabine and nab-paclitaxel plus either OGX-427 (apatorsen) or a placebo.

Participant milestones

Measure	OGX-427 OGX-427: Three separate loading doses at 600mg IV over 1 week prior to Cycle 1 of chemotherapy, followed by 600mg IV once weekly on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy. Chemotherapy: nab-paclitaxel (125mg/m\^2 IV) and gemcitabine (1000mg/m\^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment.	Placebo Placebo (dextrose 5% in water): Three separate loading doses administered over 1 week prior to Cycle 1 of chemotherapy, followed by weekly doses on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy. Chemotherapy: nab-paclitaxel (125mg/m\^2 IV) and gemcitabine (1000mg/m\^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment.
Enrolled and Randomized STARTED	66	66
Enrolled and Randomized COMPLETED	64	63
Enrolled and Randomized NOT COMPLETED	2	3
Treatment STARTED	64	63
Treatment COMPLETED	0	0
Treatment NOT COMPLETED	64	63

Reasons for withdrawal

Measure	OGX-427 OGX-427: Three separate loading doses at 600mg IV over 1 week prior to Cycle 1 of chemotherapy, followed by 600mg IV once weekly on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy. Chemotherapy: nab-paclitaxel (125mg/m\^2 IV) and gemcitabine (1000mg/m\^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment.	Placebo Placebo (dextrose 5% in water): Three separate loading doses administered over 1 week prior to Cycle 1 of chemotherapy, followed by weekly doses on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy. Chemotherapy: nab-paclitaxel (125mg/m\^2 IV) and gemcitabine (1000mg/m\^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment.
Enrolled and Randomized Withdrawal by Subject	2	3
Treatment Progressive Disease	27	36
Treatment Adverse Event	17	9
Treatment Withdrawal by Subject	10	6
Treatment Death	10	8
Treatment Lost to Follow-up	0	1
Treatment Other	0	3

Baseline Characteristics

Phase II Trial Of Gemcitabine Plus Nab-Paclitaxel +/- OGX-427 In Patients With Metastatic Pancreatic Cancer

Baseline characteristics by cohort

Measure	OGX-427 n=66 Participants OGX-427: Three separate loading doses at 600mg IV over 1 week prior to Cycle 1 of chemotherapy, followed by 600mg IV once weekly on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy. Chemotherapy: nab-paclitaxel (125mg/m\^2 IV) and gemcitabine (1000mg/m\^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment.	Placebo n=66 Participants Placebo (Dextrose 5% in Water): Three separate loading doses administered over 1 week prior to Cycle 1 of chemotherapy, followed by weekly doses on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy. Chemotherapy: nab-paclitaxel (125mg/m\^2 IV) and gemcitabine (1000mg/m\^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment.	Total n=132 Participants Total of all reporting groups
Age, Continuous	66.5 years n=5 Participants	65.5 years n=7 Participants	66 years n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	28 Participants n=7 Participants	57 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants	38 Participants n=7 Participants	75 Participants n=5 Participants
Race/Ethnicity, Customized White	56 Participants n=5 Participants	61 Participants n=7 Participants	117 Participants n=5 Participants
Race/Ethnicity, Customized Black/African American	10 Participants n=5 Participants	5 Participants n=7 Participants	15 Participants n=5 Participants
Region of Enrollment United States	66 participants n=5 Participants	66 participants n=7 Participants	132 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 2 years

Population: Includes Intent-to-Treat Population: all subjects enrolled and randomized

Overall survival defined as the time, in months, from date of randomization until date of death or date last known alive whichever comes first, assessed up to 2 years.

Outcome measures

Measure	OGX-427 n=66 Participants OGX-427: Three separate loading doses at 600mg IV over 1 week prior to Cycle 1 of chemotherapy, followed by 600mg IV once weekly on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy. Chemotherapy: nab-paclitaxel (125mg/m\^2 IV) and gemcitabine (1000mg/m\^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment.	Placebo n=66 Participants Placebo (Dextrose 5% in Water): Three separate loading doses administered over 1 week prior to Cycle 1 of chemotherapy, followed by weekly doses on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy. Chemotherapy: nab-paclitaxel (125mg/m\^2 IV) and gemcitabine (1000mg/m\^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment.
Overall Survival	5.3 months Interval 3.2 to 7.0	6.9 months Interval 5.8 to 9.3

SECONDARY outcome

Timeframe: Every 8 weeks up to 2 years

Population: Intent-to-Treat Population: all subjects enrolled and randomized

The time (in months) that patients are progression-free, assessed from date of randomization to date of first documented disease progression or date of death from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest (nadir) sum while on study (this includes the baseline sum if that is the smallest on study), or the appearance of one or more new lesions.

Outcome measures

Measure	OGX-427 n=66 Participants OGX-427: Three separate loading doses at 600mg IV over 1 week prior to Cycle 1 of chemotherapy, followed by 600mg IV once weekly on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy. Chemotherapy: nab-paclitaxel (125mg/m\^2 IV) and gemcitabine (1000mg/m\^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment.	Placebo n=66 Participants Placebo (Dextrose 5% in Water): Three separate loading doses administered over 1 week prior to Cycle 1 of chemotherapy, followed by weekly doses on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy. Chemotherapy: nab-paclitaxel (125mg/m\^2 IV) and gemcitabine (1000mg/m\^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment.
Progression-Free Survival	2.7 months Interval 2.2 to 3.7	3.8 months Interval 2.3 to 4.7

SECONDARY outcome

Timeframe: Every 8 weeks for up to 2 years

Population: Includes Intent-to-Treat Population: all subjects enrolled and randomized

Objective response rate defined as the percent of patients having a complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR=complete disappearance of all target lesions. PR=decrease in baseline of 30% or more of the diameter(s) of all target lesions.

Outcome measures

Measure	OGX-427 n=66 Participants OGX-427: Three separate loading doses at 600mg IV over 1 week prior to Cycle 1 of chemotherapy, followed by 600mg IV once weekly on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy. Chemotherapy: nab-paclitaxel (125mg/m\^2 IV) and gemcitabine (1000mg/m\^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment.	Placebo n=66 Participants Placebo (Dextrose 5% in Water): Three separate loading doses administered over 1 week prior to Cycle 1 of chemotherapy, followed by weekly doses on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy. Chemotherapy: nab-paclitaxel (125mg/m\^2 IV) and gemcitabine (1000mg/m\^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment.
Objective Response Rate PR	18 percentage of participants	18 percentage of participants
Objective Response Rate CR	0 percentage of participants	0 percentage of participants

Adverse Events

OGX-427

Serious events: 64 serious events

Other events: 62 other events

Deaths: 0 deaths

Placebo

Serious events: 63 serious events

Other events: 62 other events

Deaths: 0 deaths

Serious adverse events

Measure	OGX-427 n=64 participants at risk OGX-427: Three separate loading doses at 600mg IV over 1 week prior to Cycle 1 of chemotherapy, followed by 600mg IV once weekly on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy. Chemotherapy: nab-paclitaxel (125mg/m\^2 IV) and gemcitabine (1000mg/m\^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment.	Placebo n=63 participants at risk Placebo (dextrose 5% in water): Three separate loading doses administered over 1 week prior to Cycle 1 of chemotherapy, followed by weekly doses on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy. Chemotherapy: nab-paclitaxel (125mg/m\^2 IV) and gemcitabine (1000mg/m\^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment.
Metabolism and nutrition disorders Dehydration	28.1% 18/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	19.0% 12/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Infections and infestations Sepsis	28.1% 18/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	14.3% 9/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Abdominal Pain	18.8% 12/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	14.3% 9/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Infections and infestations Pneumonia	18.8% 12/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	9.5% 6/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Renal and urinary disorders Acute Kidney Injury	18.8% 12/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	4.8% 3/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Blood and lymphatic system disorders Anaemia	14.1% 9/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	9.5% 6/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Cardiac disorders Atrial Fibrillation	14.1% 9/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	9.5% 6/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Hepatobiliary disorders Bile Duct Obstruction	14.1% 9/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	4.8% 3/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Vascular disorders Deep Vein Thrombosis	4.7% 3/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	14.3% 9/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Diarrhoea	9.4% 6/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	9.5% 6/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Gastrointestinal Haemorrhage	14.1% 9/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	4.8% 3/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	14.1% 9/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	4.8% 3/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
General disorders Pyrexia	18.8% 12/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	0.00% 0/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Infections and infestations Cellulitis	4.7% 3/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	9.5% 6/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Obstruction Gastric	0.00% 0/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	14.3% 9/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Vomiting	4.7% 3/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	9.5% 6/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Cardiac disorders Acute Myocardial Infarction	4.7% 3/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	4.8% 3/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Cardiac disorders Cardiac Failure Congestive	0.00% 0/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	9.5% 6/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Vascular disorders Cerebrovascular Accident	9.4% 6/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	0.00% 0/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
General disorders Device Occlusion	0.00% 0/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	9.5% 6/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
General disorders Fatigue	9.4% 6/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	0.00% 0/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Blood and lymphatic system disorders Haemolytic Uraemic Syndrome	4.7% 3/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	4.8% 3/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Metabolism and nutrition disorders Hyponatraemia	4.7% 3/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	4.8% 3/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Nausea	4.7% 3/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	4.8% 3/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Renal and urinary disorders Renal Failure	4.7% 3/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	4.8% 3/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	4.7% 3/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	4.8% 3/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Hepatobiliary disorders Small Intestine Obstruction	4.7% 3/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	4.8% 3/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Abdominal Pain Upper	4.7% 3/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	0.00% 0/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Immune system disorders Anaphylactic Reaction	4.7% 3/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	0.00% 0/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Ascites	0.00% 0/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	4.8% 3/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
General disorders Asthenia	0.00% 0/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	4.8% 3/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Skin and subcutaneous tissue disorders Bacteraemia	0.00% 0/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	4.8% 3/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Hepatobiliary disorders Biliary Tract Infection	0.00% 0/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	4.8% 3/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Infections and infestations Bursitis Infective Staphylococcal	0.00% 0/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	4.8% 3/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Cardiac disorders Cardiac Arrest	0.00% 0/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	4.8% 3/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
General disorders Chest Pain	4.7% 3/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	0.00% 0/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Infections and infestations Cholangitis Infective	4.7% 3/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	0.00% 0/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Constipation	4.7% 3/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	0.00% 0/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Metabolism and nutrition disorders Decreased Appetite	0.00% 0/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	4.8% 3/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
General disorders Device Related Infection	0.00% 0/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	4.8% 3/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Duodenal Obstruction	4.7% 3/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	0.00% 0/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Duodenal Stenosis	4.7% 3/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	0.00% 0/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Metabolism and nutrition disorders Electrolyte Imbalance	0.00% 0/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	4.8% 3/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Investigations Failure to Thrive	0.00% 0/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	4.8% 3/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Blood and lymphatic system disorders Febrile Neutropeniua	0.00% 0/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	4.8% 3/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Gastric Varices Haemorrhage	0.00% 0/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	4.8% 3/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Gastritis	4.7% 3/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	0.00% 0/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Gastritis Erosive	4.7% 3/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	0.00% 0/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Hepatobiliary disorders Haematochezia	0.00% 0/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	4.8% 3/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Haemorrhagic Ascites	0.00% 0/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	4.8% 3/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Blood and lymphatic system disorders Hypotension	0.00% 0/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	4.8% 3/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Ileus Spastic	0.00% 0/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	4.8% 3/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Intestinal Obstruction	4.7% 3/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	0.00% 0/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Intestinal Perforation	0.00% 0/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	4.8% 3/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Vascular disorders Ischaemic Stroke	4.7% 3/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	0.00% 0/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Infections and infestations Klebsiella Infection	4.7% 3/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	0.00% 0/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Large Intestine Perforation	4.7% 3/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	0.00% 0/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
General disorders Lethargy	4.7% 3/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	0.00% 0/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
General disorders Mucosal Inflammation	4.7% 3/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	0.00% 0/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Blood and lymphatic system disorders Neutropenia	4.7% 3/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	0.00% 0/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Nervous system disorders Oedema Peripheral	4.7% 3/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	0.00% 0/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Pancreatitis Acute	0.00% 0/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	4.8% 3/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Peptic Ulcer	4.7% 3/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	0.00% 0/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Nervous system disorders Systemic Inflammatory Response	4.7% 3/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	0.00% 0/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Infections and infestations Urinary Tract Infection	0.00% 0/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	4.8% 3/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Renal and urinary disorders Urosepsis	4.7% 3/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	0.00% 0/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

Other adverse events

Measure	OGX-427 n=64 participants at risk OGX-427: Three separate loading doses at 600mg IV over 1 week prior to Cycle 1 of chemotherapy, followed by 600mg IV once weekly on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy. Chemotherapy: nab-paclitaxel (125mg/m\^2 IV) and gemcitabine (1000mg/m\^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment.	Placebo n=63 participants at risk Placebo (dextrose 5% in water): Three separate loading doses administered over 1 week prior to Cycle 1 of chemotherapy, followed by weekly doses on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy. Chemotherapy: nab-paclitaxel (125mg/m\^2 IV) and gemcitabine (1000mg/m\^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment.
Blood and lymphatic system disorders Anaemia	56.2% 36/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	63.5% 40/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Blood and lymphatic system disorders Thrombocytopenia	42.2% 27/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	33.3% 21/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Blood and lymphatic system disorders Neutropenia	28.1% 18/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	33.3% 21/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Blood and lymphatic system disorders Leukopenia	12.5% 8/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	9.5% 6/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Nausea	53.1% 34/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	63.5% 40/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Abdominal Pain	40.6% 26/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	33.3% 21/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Diarrhoea	43.8% 28/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	28.6% 18/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Vomiting	40.6% 26/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	31.7% 20/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Constipation	31.2% 20/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	34.9% 22/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Dyspepsia	10.9% 7/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	7.9% 5/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Ascites	7.8% 5/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	7.9% 5/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Flatulence	6.2% 4/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	9.5% 6/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Abdominal Pain Upper	10.9% 7/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	3.2% 2/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Stomatitis	9.4% 6/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	4.8% 3/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Gastroesophageal Reflux	6.2% 4/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	6.3% 4/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Abdominal Distention	4.7% 3/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	6.3% 4/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
General disorders Fatigure	64.1% 41/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	69.8% 44/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
General disorders Oedema Peripheral	40.6% 26/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	25.4% 16/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
General disorders Pyrexia	32.8% 21/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	27.0% 17/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
General disorders Asthenia	14.1% 9/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	17.5% 11/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
General disorders Chills	6.2% 4/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	14.3% 9/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
General disorders Pain	7.8% 5/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	6.3% 4/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
General disorders Peripheral Swelling	3.1% 2/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	11.1% 7/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
General disorders Mucosal Inflammation	6.2% 4/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	4.8% 3/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Metabolism and nutrition disorders Decreased Appetite	35.9% 23/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	34.9% 22/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Metabolism and nutrition disorders Dehydration	25.0% 16/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	28.6% 18/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Metabolism and nutrition disorders Hypokalaemia	15.6% 10/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	12.7% 8/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Metabolism and nutrition disorders Hyponatraemia	14.1% 9/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	9.5% 6/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Metabolism and nutrition disorders Hyperglycaemia	10.9% 7/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	7.9% 5/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Metabolism and nutrition disorders Hyperalbuminaemia	6.2% 4/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	11.1% 7/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Metabolism and nutrition disorders Hypocalcaemia	7.8% 5/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	4.8% 3/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Investigations Alanine Aminotransferase Increased	25.0% 16/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	25.4% 16/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Psychiatric disorders Depression	12.5% 8/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	3.2% 2/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Investigations Aspartate Aminotransferase Increased	25.0% 16/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	20.6% 13/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Investigations Platelet Count Decreased	25.0% 16/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	17.5% 11/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Investigations Blood Alkaline Phosphatase Increased	17.2% 11/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	20.6% 13/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Investigations Weight Decreased	18.8% 12/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	19.0% 12/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Investigations Neutrophil Count Decreased	9.4% 6/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	14.3% 9/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Investigations Blood Bilirubin Increased	10.9% 7/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	11.1% 7/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Investigations Blood Creatinine Increased	12.5% 8/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	6.3% 4/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Infections and infestations Urinary Tract Infections	14.1% 9/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	6.3% 4/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Infections and infestations Pneumonia	9.4% 6/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	4.8% 3/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Infections and infestations Sepsis	7.8% 5/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	6.3% 4/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Infections and infestations Upper Respiratory Track Infection	9.4% 6/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	3.2% 2/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Skin and subcutaneous tissue disorders Alopecia	25.0% 16/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	23.8% 15/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Skin and subcutaneous tissue disorders Rash	14.1% 9/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	25.4% 16/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Skin and subcutaneous tissue disorders Pruritis	6.2% 4/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	4.8% 3/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Respiratory, thoracic and mediastinal disorders Dyspnoea	23.4% 15/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	19.0% 12/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Respiratory, thoracic and mediastinal disorders Cough	20.3% 13/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	9.5% 6/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	9.4% 6/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	7.9% 5/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Respiratory, thoracic and mediastinal disorders Epistaxis	6.2% 4/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	7.9% 5/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Musculoskeletal and connective tissue disorders Pain in Extremity	9.4% 6/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	11.1% 7/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Musculoskeletal and connective tissue disorders Muscular Weakness	7.8% 5/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	11.1% 7/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Musculoskeletal and connective tissue disorders Myalgia	10.9% 7/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	7.9% 5/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Musculoskeletal and connective tissue disorders Arthralgia	12.5% 8/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	4.8% 3/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Musculoskeletal and connective tissue disorders Back Pain	7.8% 5/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	4.8% 3/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Psychiatric disorders Insomnia	15.6% 10/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	23.8% 15/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Psychiatric disorders Anxiety	10.9% 7/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	12.7% 8/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Vascular disorders Hypotension	12.5% 8/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	15.9% 10/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Vascular disorders Deep Vein Thrombosis	6.2% 4/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	12.7% 8/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Vascular disorders Hypertension	6.2% 4/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	11.1% 7/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Vascular disorders Flushing	6.2% 4/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	7.9% 5/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Renal and urinary disorders Acute Kidney Injury	9.4% 6/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	4.8% 3/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Cardiac disorders Tachycardia	7.8% 5/64 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	7.9% 5/63 • weekly for approximately 24 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

Additional Information

Charles Davis, RAC

Sarah Cannon Development Innovations

Email: Charles.Davis2@scri-innovations.com

Results disclosure agreements

• Principal investigator is a sponsor employee The sponsor can review/embargo results communications prior to public release for a period that is \>60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites.
• Publication restrictions are in place

Restriction type: OTHER