Trial Outcomes & Findings for BBR 2778 for Relapsed, Aggressive Non-Hodgkin's Lymphoma (NHL) (NCT NCT00088530)

Last Updated: 2020-02-05

Results Overview

Proportion of patients with a best response of complete response (CR) or Complete Response unconfirmed (CRu) in the End Of Treatment (EOT) or End Of Study (EOS) analyses by independent assessment in the Intent-to-treat (ITT) population through the End of Treatment (EOT)

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

140 participants

Primary outcome timeframe

EOT; approximately 6 months

Results posted on

2020-02-05

Participant Flow

Patients were enrolled from 66 sites: 6 in the U.S, 4 in France, 3 in Bulgaria, 4 sites in Hungary, 3 in Ukraine, 11 in Italy, 2 in Romania, 3 in United Kingdom, 2 in Poland, 2 in Germany, 3 in Peru, 6 in Argentina, 1 in Colombia, 2 in Ecuador, 1 in Uruguay, 5 in Russia and 8 in India.

Participant milestones

Participant milestones
Measure	Experimental Group Pixantrone (BBR 2778) 85 mg/m2 on days 1, 8 and 15 of each 28-day cycle)	Comparator Group Vinorelbine or Oxalplatin or Ifosfasmide or Etoposide or Mitoxatrone or Gemcitabine or Rituximab
Overall Study STARTED	70	70
Overall Study COMPLETED	20	16
Overall Study NOT COMPLETED	50	54

Reasons for withdrawal

Reasons for withdrawal
Measure	Experimental Group Pixantrone (BBR 2778) 85 mg/m2 on days 1, 8 and 15 of each 28-day cycle)	Comparator Group Vinorelbine or Oxalplatin or Ifosfasmide or Etoposide or Mitoxatrone or Gemcitabine or Rituximab
Overall Study Progressive/Relapsed Disease	28	39
Overall Study Adverse Event	15	9
Overall Study Withdrawal by Subject	2	5
Overall Study Lost to Follow-up	2	0
Overall Study Physician Decision	2	0
Overall Study Sponsor decision	0	1
Overall Study Patient never treated	1	0

Baseline Characteristics

BBR 2778 for Relapsed, Aggressive Non-Hodgkin's Lymphoma (NHL)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental Group n=70 Participants Pixantrone (BBR 2778) 85 mg/m2 on days 1, 8 and 15 of each 28-day cycle	Comparator Group n=70 Participants Vinorelbine or Oxalplatin or Ifosfasmide or Etoposide or Mitoxatrone or Gemcitabine or Rituximab	Total n=140 Participants Total of all reporting groups
Age, Continuous Age at Randomization (years)	58.2 years STANDARD_DEVIATION 13.5 • n=99 Participants	56.2 years STANDARD_DEVIATION 12.9 • n=107 Participants	57.2 years STANDARD_DEVIATION 13.2 • n=206 Participants
Age, Customized 18 to < 30	5 Participants n=99 Participants	2 Participants n=107 Participants	7 Participants n=206 Participants
Age, Customized 30 to < 40	2 Participants n=99 Participants	9 Participants n=107 Participants	11 Participants n=206 Participants
Age, Customized 40 to < 50	9 Participants n=99 Participants	7 Participants n=107 Participants	16 Participants n=206 Participants
Age, Customized 50 to < 60	18 Participants n=99 Participants	21 Participants n=107 Participants	39 Participants n=206 Participants
Age, Customized 60 to < 70	20 Participants n=99 Participants	21 Participants n=107 Participants	41 Participants n=206 Participants
Age, Customized 70 to < 80	15 Participants n=99 Participants	9 Participants n=107 Participants	24 Participants n=206 Participants
Age, Customized ≥ 80	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants
Sex: Female, Male Female	24 Participants n=99 Participants	30 Participants n=107 Participants	54 Participants n=206 Participants
Sex: Female, Male Male	46 Participants n=99 Participants	40 Participants n=107 Participants	86 Participants n=206 Participants
Race/Ethnicity, Customized Caucasian	46 Participants n=99 Participants	44 Participants n=107 Participants	90 Participants n=206 Participants
Race/Ethnicity, Customized Black	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race/Ethnicity, Customized Asian	10 Participants n=99 Participants	13 Participants n=107 Participants	23 Participants n=206 Participants
Race/Ethnicity, Customized Hispanic	7 Participants n=99 Participants	6 Participants n=107 Participants	13 Participants n=206 Participants
Race/Ethnicity, Customized Native American	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants
Race/Ethnicity, Customized Other	6 Participants n=99 Participants	6 Participants n=107 Participants	12 Participants n=206 Participants
Region of Enrollment North America	4 participants n=99 Participants	4 participants n=107 Participants	8 participants n=206 Participants
Region of Enrollment Argentina	6 participants n=99 Participants	5 participants n=107 Participants	11 participants n=206 Participants
Region of Enrollment Bulgaria	6 participants n=99 Participants	3 participants n=107 Participants	9 participants n=206 Participants
Region of Enrollment Colombia	1 participants n=99 Participants	0 participants n=107 Participants	1 participants n=206 Participants
Region of Enrollment Ecuador	3 participants n=99 Participants	4 participants n=107 Participants	7 participants n=206 Participants
Region of Enrollment Hungary	5 participants n=99 Participants	5 participants n=107 Participants	10 participants n=206 Participants
Region of Enrollment India	9 participants n=99 Participants	12 participants n=107 Participants	21 participants n=206 Participants
Region of Enrollment Peru	9 participants n=99 Participants	8 participants n=107 Participants	17 participants n=206 Participants
Region of Enrollment Poland	2 participants n=99 Participants	0 participants n=107 Participants	2 participants n=206 Participants
Region of Enrollment Romania	1 participants n=99 Participants	1 participants n=107 Participants	2 participants n=206 Participants
Region of Enrollment Russian Federation	4 participants n=99 Participants	5 participants n=107 Participants	9 participants n=206 Participants
Region of Enrollment Ukraine	1 participants n=99 Participants	3 participants n=107 Participants	4 participants n=206 Participants
Region of Enrollment Uruguay	0 participants n=99 Participants	1 participants n=107 Participants	1 participants n=206 Participants
Region of Enrollment France	4 participants n=99 Participants	4 participants n=107 Participants	8 participants n=206 Participants
Region of Enrollment United Kingdom	4 participants n=99 Participants	3 participants n=107 Participants	7 participants n=206 Participants
Region of Enrollment Germany	3 participants n=99 Participants	0 participants n=107 Participants	3 participants n=206 Participants
Region of Enrollment Italy	8 participants n=99 Participants	12 participants n=107 Participants	20 participants n=206 Participants
Baseline ECOG Performance Status 0	26 Participants n=99 Participants	23 Participants n=107 Participants	49 Participants n=206 Participants
Baseline ECOG Performance Status 1	30 Participants n=99 Participants	32 Participants n=107 Participants	62 Participants n=206 Participants
Baseline ECOG Performance Status 2	14 Participants n=99 Participants	14 Participants n=107 Participants	28 Participants n=206 Participants
Baseline ECOG Performance Status 3	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants

PRIMARY outcome

Timeframe: EOT; approximately 6 months

Population: Intent to Treat (all randomized patients)

Outcome measures

Outcome measures
Measure	Experimental Group n=70 Participants Pixantrone (BBR 2778) 85 mg/m2 on days 1, 8 and 15 of each 28-day cycle	Comparator Group n=70 Participants Vinorelbine or Oxalplatin or Ifosfasmide or Etoposide or Mitoxatrone or Gemcitabine or Rituximab
Complete Response (CR) and Complete Response Unconfirmed (CRu) END OF TREATMENT: CR/CRu, n (%)	20.0 percentage of randomized patients Interval 11.4 to 31.3	5.7 percentage of randomized patients Interval 1.6 to 14.0
Complete Response (CR) and Complete Response Unconfirmed (CRu) END OF STUDY: CR/CRu, n (%)	24.3 percentage of randomized patients Interval 14.8 to 36.0	7.1 percentage of randomized patients Interval 2.4 to 15.9

SECONDARY outcome

Timeframe: 18 months after 6 cycles of treatment; approximately 24 months

Population: Intent-to-treat patients

The time between the date of randomization and the date of the initial documentation of progressive/relapsed disease or death due to any cause.

Outcome measures

Outcome measures
Measure	Experimental Group n=70 Participants Pixantrone (BBR 2778) 85 mg/m2 on days 1, 8 and 15 of each 28-day cycle	Comparator Group n=70 Participants Vinorelbine or Oxalplatin or Ifosfasmide or Etoposide or Mitoxatrone or Gemcitabine or Rituximab
Progression-Free Survival (PFS)	5.3 months Interval 2.3 to 6.2	2.6 months Interval 1.9 to 3.5

SECONDARY outcome

Timeframe: 18 months after 6 cycles of treatment; approximately 24 months

Population: Intent-To-Treat (ITT) Population.

The time between the date of randomization and the date of death due to any cause.

Outcome measures

Outcome measures
Measure	Experimental Group n=70 Participants Pixantrone (BBR 2778) 85 mg/m2 on days 1, 8 and 15 of each 28-day cycle	Comparator Group n=70 Participants Vinorelbine or Oxalplatin or Ifosfasmide or Etoposide or Mitoxatrone or Gemcitabine or Rituximab
Overall Survival	10.2 Months Interval 6.4 to 15.7	7.6 Months Interval 5.4 to 9.3

SECONDARY outcome

Timeframe: approximately 24 months

Population: Intent-To-Treat (ITT) population

The proportion of patients with Complete response or Partial Response with a difference from the first documented objective response to disease progression or death of at least 4 months.

Outcome measures

Outcome measures
Measure	Experimental Group n=70 Participants Pixantrone (BBR 2778) 85 mg/m2 on days 1, 8 and 15 of each 28-day cycle	Comparator Group n=70 Participants Vinorelbine or Oxalplatin or Ifosfasmide or Etoposide or Mitoxatrone or Gemcitabine or Rituximab
Overall Response Rate (ORR) Lasting at Least 4 Months	12 participants	6 participants

Adverse Events

Experimental Group

Serious events: 35 serious events

Other events: 66 other events

Deaths: 49 deaths

Comparator Group

Serious events: 30 serious events

Other events: 61 other events

Deaths: 52 deaths

Serious adverse events

Other adverse events

Additional Information

Simran Bedi Singh

CTIBioPharma Corp.

Phone: (206) 272-4000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Serious adverse events
Measure	Experimental Group n=68 participants at risk Pixantrone (BBR 2778) 85 mg/m2 on days 1, 8 and 15 of each 28-day cycle	Comparator Group n=67 participants at risk Vinorelbine or Oxalplatin or Ifosfasmide or Etoposide or Mitoxatrone or Gemcitabine or Rituximab
Blood and lymphatic system disorders Neutropenia	13.2% 9/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	9.0% 6/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Blood and lymphatic system disorders Thrombocytopenia	1.5% 1/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	9.0% 6/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Blood and lymphatic system disorders Anemia	2.9% 2/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	7.5% 5/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Blood and lymphatic system disorders Febrile neutropenia	5.9% 4/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	3.0% 2/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Blood and lymphatic system disorders Leukopenia	5.9% 4/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	3.0% 2/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Hepatobiliary disorders Cholestasis	1.5% 1/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	0.00% 0/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Eye disorders Keratitis	1.5% 1/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	0.00% 0/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Hepatobiliary disorders Jaundice	1.5% 1/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	0.00% 0/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	4.4% 3/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	3.0% 2/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.9% 2/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	0.00% 0/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	2.9% 2/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	3.0% 2/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Distress Syndrome	1.5% 1/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	0.00% 0/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	1.5% 1/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	0.00% 0/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Respiratory, thoracic and mediastinal disorders Obstructive Airways disorder	1.5% 1/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	1.5% 1/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	1.5% 1/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	3.0% 2/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Respiratory, thoracic and mediastinal disorders Pulmonary Venous Thrombosis	1.5% 1/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	0.00% 0/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Skin and subcutaneous tissue disorders Skin Ulcer	1.5% 1/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	0.00% 0/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Vascular disorders Hypotension	4.4% 3/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	3.0% 2/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Vascular disorders Circulatory Collapse	1.5% 1/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	0.00% 0/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Vascular disorders Deep Vein Thrombosis	1.5% 1/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	1.5% 1/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	1.5% 1/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	1.5% 1/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Cardiac disorders Cardiac Failure	2.9% 2/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	1.5% 1/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Cardiac disorders Cardiac Failure Congestive	2.9% 2/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	0.00% 0/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Cardiac disorders Cardiac Arrest	1.5% 1/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	0.00% 0/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Cardiac disorders Cyanosis	1.5% 1/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	0.00% 0/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Cardiac disorders Myocardial Ischaemia	1.5% 1/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	0.00% 0/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Cardiac disorders Myocarditis	0.00% 0/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	1.5% 1/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Cardiac disorders Pericardial Effusion	1.5% 1/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	0.00% 0/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Cardiac disorders Sinus Tachycardia	0.00% 0/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	1.5% 1/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Cardiac disorders Tachycardia	1.5% 1/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	0.00% 0/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Cardiac disorders Ventricular Extrasystoles	0.00% 0/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	1.5% 1/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Gastrointestinal disorders Abdominal Pain	4.4% 3/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	4.5% 3/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Gastrointestinal disorders Vomiting	0.00% 0/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	3.0% 2/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Gastrointestinal disorders Abdominal Distension	0.00% 0/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	1.5% 1/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Gastrointestinal disorders Diarrhoea	0.00% 0/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	1.5% 1/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Gastrointestinal disorders Dysphagia	0.00% 0/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	1.5% 1/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Gastrointestinal disorders Ileus	1.5% 1/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	0.00% 0/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Gastrointestinal disorders Nausea	0.00% 0/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	1.5% 1/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
General disorders Pyrexia	10.3% 7/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	10.4% 7/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.

Other adverse events
Measure	Experimental Group n=68 participants at risk Pixantrone (BBR 2778) 85 mg/m2 on days 1, 8 and 15 of each 28-day cycle	Comparator Group n=67 participants at risk Vinorelbine or Oxalplatin or Ifosfasmide or Etoposide or Mitoxatrone or Gemcitabine or Rituximab
Blood and lymphatic system disorders Anemia	30.9% 21/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	32.8% 22/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Blood and lymphatic system disorders Neutropenia	50.0% 34/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	23.9% 16/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Blood and lymphatic system disorders Leukopenia	25.0% 17/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	10.4% 7/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Blood and lymphatic system disorders Thrombocytopenia	20.6% 14/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	19.4% 13/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Blood and lymphatic system disorders Febrile Neutropenia	8.8% 6/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	3.0% 2/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Blood and lymphatic system disorders Lymphadenopathy	2.9% 2/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	7.5% 5/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Cardiac disorders Cardiac Disorders	20.6% 14/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	13.4% 9/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Gastrointestinal disorders Nausea	17.6% 12/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	16.4% 11/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Gastrointestinal disorders Abdominal Pain	16.2% 11/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	10.4% 7/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Gastrointestinal disorders Constipation	11.8% 8/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	4.5% 3/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Gastrointestinal disorders Vomiting	7.4% 5/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	14.9% 10/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Gastrointestinal disorders Diarrhea	4.4% 3/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	17.9% 12/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
General disorders Asthenia	23.5% 16/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	13.4% 9/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
General disorders Pyrexia	23.5% 16/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	23.9% 16/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
General disorders Edema peripheral	14.7% 10/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	6.0% 4/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
General disorders Fatigue	13.2% 9/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	13.4% 9/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
General disorders Mucosal inflammation	11.8% 8/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	3.0% 2/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Infections and infestations Pneumonia	7.4% 5/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	6.0% 4/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Infections and infestations Bronchitis	5.9% 4/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	0.00% 0/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Infections and infestations Cellulitis	5.9% 4/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	3.0% 2/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Investigations Ejection fraction decreased	19.1% 13/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	10.4% 7/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Investigations Weight Decreased	7.4% 5/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	7.5% 5/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Investigations Platelet count decreased	5.9% 4/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	3.0% 2/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Metabolism and nutrition disorders Anorexia	11.8% 8/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	6.0% 4/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Metabolism and nutrition disorders Dehydration	7.4% 5/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	3.0% 2/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Musculoskeletal and connective tissue disorders Pain in extremity	7.4% 5/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	3.0% 2/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Musculoskeletal and connective tissue disorders Back pain	8.8% 6/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	3.0% 2/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	1.5% 1/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	13.4% 9/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Renal and urinary disorders Chromaturia	5.9% 4/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	0.00% 0/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Renal and urinary disorders Renal failure	0.00% 0/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	7.5% 5/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Respiratory, thoracic and mediastinal disorders Cough	22.1% 15/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	4.5% 3/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Respiratory, thoracic and mediastinal disorders Dyspnea	13.2% 9/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	13.4% 9/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Respiratory, thoracic and mediastinal disorders Rhinorrhea	5.9% 4/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	0.00% 0/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Respiratory, thoracic and mediastinal disorders Pleural effusion	4.4% 3/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	6.0% 4/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Skin and subcutaneous tissue disorders Alopecia	13.2% 9/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	4.5% 3/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Skin and subcutaneous tissue disorders Skin Discoloration	10.3% 7/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	0.00% 0/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.
Vascular disorders Hypotension	7.4% 5/68 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.	4.5% 3/67 • 2 year, 3 months. Adverse event tables presented include data reported through End Of Study An adverse event was defined as any noxious and unintended sign, symptom, or disease that began or worsened from the time the patient signed the Informed Consent Form to participate in the study until 30 days after last study treatment, regardless of whether event was considered related or unrelated to study drug. Treatment emergent adverse events were summarized in the table below (patients who received study drug - 68/67). NCI CTCAE V3 was used to assess toxicities observed during the study.