Trial Outcomes & Findings for Tivantinib With or Without Erlotinib Hydrochloride in Treating Patients With Metastatic or Locally Advanced Kidney Cancer That Cannot Be Removed by Surgery (NCT NCT01688973)

NCT ID: NCT01688973

Last Updated: 2019-01-03

Results Overview

Best Response is calculated from the sequence of objective statuses. CR: Two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. PR: Two or more objective statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration, but not qualifying as CR. Stable/no response: At least one objective status of stable/no response documented at least 6 weeks after registration and before progression or symptomatic deterioration, but not qualifying as anything else above. Increasing disease: Objective status of progression within 12 weeks of registration, not qualifying as anything else above. Symptomatic deterioration: Objective status of symptomatic deterioration within 12 weeks of registration, not qualifying as anything else above.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 55 participants
• Primary outcome timeframe: Up to 3 years
• Results posted on: 2019-01-03

Participant Flow

Participant milestones

Measure	Arm I (Tivantinib) Patients receive tivantinib PO BID on days 1-28. Laboratory Biomarker Analysis: Correlative studies Tivantinib: Given PO	Arm II (Tivantinib and Erlotinib Hydrochloride) Patients receive tivantinib PO BID and erlotinib hydrochloride PO QD on days 1-28. Erlotinib Hydrochloride: Given PO Laboratory Biomarker Analysis: Correlative studies Tivantinib: Given PO
Overall Study STARTED	27	28
Overall Study Eligible/Evaluable Patients	25	25
Overall Study COMPLETED	25	25
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Measure	Arm I (Tivantinib) Patients receive tivantinib PO BID on days 1-28. Laboratory Biomarker Analysis: Correlative studies Tivantinib: Given PO	Arm II (Tivantinib and Erlotinib Hydrochloride) Patients receive tivantinib PO BID and erlotinib hydrochloride PO QD on days 1-28. Erlotinib Hydrochloride: Given PO Laboratory Biomarker Analysis: Correlative studies Tivantinib: Given PO
Overall Study Ineligible	2	3

Baseline Characteristics

Tivantinib With or Without Erlotinib Hydrochloride in Treating Patients With Metastatic or Locally Advanced Kidney Cancer That Cannot Be Removed by Surgery

Baseline characteristics by cohort

Measure	Arm I (Tivantinib) n=25 Participants Patients receive tivantinib PO BID on days 1-28. Laboratory Biomarker Analysis: Correlative studies Tivantinib: Given PO	Arm II (Tivantinib and Erlotinib Hydrochloride) n=25 Participants Patients receive tivantinib PO BID and erlotinib hydrochloride PO QD on days 1-28. Erlotinib Hydrochloride: Given PO Laboratory Biomarker Analysis: Correlative studies Tivantinib: Given PO	Total n=50 Participants Total of all reporting groups
Age, Continuous	62.1 years n=5 Participants	63.6 years n=7 Participants	63.6 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	10 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	15 Participants n=7 Participants	34 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	19 Participants n=5 Participants	19 Participants n=7 Participants	38 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Race/Ethnicity, Customized Race · Unknown	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Histologic Grade Unknown	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Histologic Grade 1	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Histologic Grade 2	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Histologic Grade 3	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Histologic Grade 4	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Histologic Subset Pure Papillary	20 Participants n=5 Participants	23 Participants n=7 Participants	43 Participants n=5 Participants
Histologic Subset Mixed Histology	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Histologic Type Not Assigned	12 Participants n=5 Participants	14 Participants n=7 Participants	26 Participants n=5 Participants
Histologic Type Type I	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Histologic Type Type II	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Prior Nephrectomy No	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Prior Nephrectomy Yes	21 Participants n=5 Participants	18 Participants n=7 Participants	39 Participants n=5 Participants
Prior Systemic Therapy None	16 Participants n=5 Participants	17 Participants n=7 Participants	33 Participants n=5 Participants
Prior Systemic Therapy One	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Performance Status 0	12 Participants n=5 Participants	9 Participants n=7 Participants	21 Participants n=5 Participants
Performance Status 1	11 Participants n=5 Participants	13 Participants n=7 Participants	24 Participants n=5 Participants
Performance Status 2	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Performance Status 3	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Performance Status 4	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 3 years

Best Response is calculated from the sequence of objective statuses. CR: Two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration.

PR: Two or more objective statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration, but not qualifying as CR.

Stable/no response: At least one objective status of stable/no response documented at least 6 weeks after registration and before progression or symptomatic deterioration, but not qualifying as anything else above.

Increasing disease: Objective status of progression within 12 weeks of registration, not qualifying as anything else above.

Symptomatic deterioration: Objective status of symptomatic deterioration within 12 weeks of registration, not qualifying as anything else above.

Outcome measures

Measure	Arm I (Tivantinib) n=25 Participants Patients receive tivantinib PO BID on days 1-28. Laboratory Biomarker Analysis: Correlative studies Tivantinib: Given PO	Arm II (Tivantinib and Erlotinib Hydrochloride) n=25 Participants Patients receive tivantinib PO BID and erlotinib hydrochloride PO QD on days 1-28. Erlotinib Hydrochloride: Given PO Laboratory Biomarker Analysis: Correlative studies Tivantinib: Given PO
Response Rate (Confirmed Complete Response or Partial Response), Determined According to Response Evaluation Criteria in Solid Tumors Stable/no response	11 Participants	13 Participants
Response Rate (Confirmed Complete Response or Partial Response), Determined According to Response Evaluation Criteria in Solid Tumors Not Assessable	0 Participants	4 Participants
Response Rate (Confirmed Complete Response or Partial Response), Determined According to Response Evaluation Criteria in Solid Tumors Complete Response	0 Participants	0 Participants
Response Rate (Confirmed Complete Response or Partial Response), Determined According to Response Evaluation Criteria in Solid Tumors Partial Response	0 Participants	0 Participants
Response Rate (Confirmed Complete Response or Partial Response), Determined According to Response Evaluation Criteria in Solid Tumors Increasing disease	14 Participants	7 Participants
Response Rate (Confirmed Complete Response or Partial Response), Determined According to Response Evaluation Criteria in Solid Tumors Symptomatic deterioration	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to 3 years

Population: All eligible patients who reported adverse events

This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment

Outcome measures

Measure	Arm I (Tivantinib) n=25 Participants Patients receive tivantinib PO BID on days 1-28. Laboratory Biomarker Analysis: Correlative studies Tivantinib: Given PO	Arm II (Tivantinib and Erlotinib Hydrochloride) n=25 Participants Patients receive tivantinib PO BID and erlotinib hydrochloride PO QD on days 1-28. Erlotinib Hydrochloride: Given PO Laboratory Biomarker Analysis: Correlative studies Tivantinib: Given PO
Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 Alanine aminotransferase increased	0 Participants	1 Participants
Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 Fatigue	0 Participants	1 Participants
Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 Febrile neutropenia	0 Participants	1 Participants
Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 Hypertension	1 Participants	0 Participants
Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 Hypoxia	0 Participants	1 Participants
Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 Infections and infestations - Other, specify	0 Participants	1 Participants
Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 Pneumonitis	0 Participants	1 Participants
Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 Stroke	1 Participants	0 Participants
Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 Weight loss	1 Participants	0 Participants
Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 Aspartate aminotransferase increased	0 Participants	1 Participants
Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 Dyspnea	1 Participants	1 Participants
Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 Erythema multiforme	0 Participants	1 Participants
Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 Lung infection	0 Participants	1 Participants
Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 Lymphocyte count decreased	1 Participants	0 Participants
Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 Anemia	2 Participants	1 Participants
Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 Myocardial infarction	0 Participants	1 Participants
Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 Nausea	1 Participants	0 Participants
Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 Neutrophil count decreased	1 Participants	0 Participants
Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 Pain in extremity	1 Participants	0 Participants
Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 Rash acneiform	0 Participants	2 Participants
Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 Rash maculo-papular	0 Participants	1 Participants
Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 White blood cell decreased	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 30 months

From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive without report of progression are censored at date of last contact.

Outcome measures

Measure	Arm I (Tivantinib) n=25 Participants Patients receive tivantinib PO BID on days 1-28. Laboratory Biomarker Analysis: Correlative studies Tivantinib: Given PO	Arm II (Tivantinib and Erlotinib Hydrochloride) n=25 Participants Patients receive tivantinib PO BID and erlotinib hydrochloride PO QD on days 1-28. Erlotinib Hydrochloride: Given PO Laboratory Biomarker Analysis: Correlative studies Tivantinib: Given PO
Progression-free Survival (PFS)	2.0 months Interval 1.8 to 3.0	3.9 months Interval 1.8 to 7.3

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: Tissue was only obtained from 35 patients. Exome of 16 patients were successfully sequenced using Agilent SureSelect probes. Arms were pooled due to no difference in response rate between the two arms

Outcome measures

Measure	Arm I (Tivantinib) n=16 Participants Patients receive tivantinib PO BID on days 1-28. Laboratory Biomarker Analysis: Correlative studies Tivantinib: Given PO	Arm II (Tivantinib and Erlotinib Hydrochloride) Patients receive tivantinib PO BID and erlotinib hydrochloride PO QD on days 1-28. Erlotinib Hydrochloride: Given PO Laboratory Biomarker Analysis: Correlative studies Tivantinib: Given PO
Number of Participants With c-MET Amplification, Deletion and No Alteration Amplification	6 Participants	—
Number of Participants With c-MET Amplification, Deletion and No Alteration Deletion	0 Participants	—
Number of Participants With c-MET Amplification, Deletion and No Alteration No Alteration	10 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: Tissue was only obtained from 35 patients. Exome of 16 patients were successfully sequenced using Agilent SureSelect probes.

Outcome measures

Measure	Arm I (Tivantinib) n=16 Participants Patients receive tivantinib PO BID on days 1-28. Laboratory Biomarker Analysis: Correlative studies Tivantinib: Given PO	Arm II (Tivantinib and Erlotinib Hydrochloride) Patients receive tivantinib PO BID and erlotinib hydrochloride PO QD on days 1-28. Erlotinib Hydrochloride: Given PO Laboratory Biomarker Analysis: Correlative studies Tivantinib: Given PO
Number of Participants With EGFR Amplification, Deletion and No Alteration Amplification	3 Participants	—
Number of Participants With EGFR Amplification, Deletion and No Alteration Deletion	1 Participants	—
Number of Participants With EGFR Amplification, Deletion and No Alteration No Alteration	12 Participants	—

Adverse Events

Arm I (Tivantinib)

Serious events: 9 serious events

Other events: 22 other events

Deaths: 20 deaths

Arm II (Tivantinib and Erlotinib Hydrochloride)

Serious events: 16 serious events

Other events: 23 other events

Deaths: 21 deaths

Serious adverse events

Measure	Arm I (Tivantinib) n=25 participants at risk Patients receive tivantinib PO BID on days 1-28. Laboratory Biomarker Analysis: Correlative studies Tivantinib: Given PO	Arm II (Tivantinib and Erlotinib Hydrochloride) n=25 participants at risk Patients receive tivantinib PO BID and erlotinib hydrochloride PO QD on days 1-28. Erlotinib Hydrochloride: Given PO Laboratory Biomarker Analysis: Correlative studies Tivantinib: Given PO
Blood and lymphatic system disorders Anemia	4.0% 1/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	8.0% 2/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other	0.00% 0/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	4.0% 1/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	4.0% 1/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Cardiac disorders Atrial flutter	0.00% 0/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	4.0% 1/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Cardiac disorders Cardiac arrest	4.0% 1/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	0.00% 0/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Cardiac disorders Cardiac disorders-Other	0.00% 0/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	4.0% 1/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Cardiac disorders Myocardial infarction	0.00% 0/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	4.0% 1/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Cardiac disorders Sinus bradycardia	0.00% 0/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	4.0% 1/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Gastrointestinal disorders Abdominal distension	0.00% 0/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	4.0% 1/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Gastrointestinal disorders Abdominal pain	0.00% 0/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	8.0% 2/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Gastrointestinal disorders Constipation	0.00% 0/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	4.0% 1/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Gastrointestinal disorders Nausea	0.00% 0/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	4.0% 1/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	8.0% 2/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
General disorders Fatigue	4.0% 1/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	8.0% 2/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Infections and infestations Device related infection	0.00% 0/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	4.0% 1/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Infections and infestations Lung infection	0.00% 0/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	4.0% 1/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Infections and infestations Sepsis	0.00% 0/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	4.0% 1/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Investigations Alanine aminotransferase increased	0.00% 0/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	8.0% 2/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Investigations Alkaline phosphatase increased	0.00% 0/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	4.0% 1/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Investigations Aspartate aminotransferase increased	0.00% 0/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	4.0% 1/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Investigations Blood bilirubin increased	4.0% 1/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	0.00% 0/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Investigations Platelet count decreased	0.00% 0/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	4.0% 1/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Investigations Weight loss	4.0% 1/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	0.00% 0/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Investigations White blood cell decreased	0.00% 0/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	4.0% 1/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Metabolism and nutrition disorders Acidosis	0.00% 0/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	8.0% 2/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Metabolism and nutrition disorders Dehydration	0.00% 0/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	4.0% 1/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	4.0% 1/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Metabolism and nutrition disorders Hypoalbuminemia	0.00% 0/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	4.0% 1/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	4.0% 1/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	8.0% 2/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Musculoskeletal and connective tissue disorders Pain in extremity	4.0% 1/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	0.00% 0/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified - Other	8.0% 2/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	8.0% 2/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Nervous system disorders Dizziness	0.00% 0/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	4.0% 1/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Nervous system disorders Intracranial hemorrhage	0.00% 0/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	4.0% 1/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Nervous system disorders Stroke	4.0% 1/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	0.00% 0/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Renal and urinary disorders Acute kidney injury	0.00% 0/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	4.0% 1/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Renal and urinary disorders Hematuria	4.0% 1/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	4.0% 1/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Respiratory, thoracic and mediastinal disorders Dyspnea	16.0% 4/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	4.0% 1/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	4.0% 1/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	4.0% 1/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	8.0% 2/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Skin and subcutaneous tissue disorders Rash acneiform	0.00% 0/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	4.0% 1/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Vascular disorders Thromboembolic event	4.0% 1/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	4.0% 1/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.

Other adverse events

Measure	Arm I (Tivantinib) n=25 participants at risk Patients receive tivantinib PO BID on days 1-28. Laboratory Biomarker Analysis: Correlative studies Tivantinib: Given PO	Arm II (Tivantinib and Erlotinib Hydrochloride) n=25 participants at risk Patients receive tivantinib PO BID and erlotinib hydrochloride PO QD on days 1-28. Erlotinib Hydrochloride: Given PO Laboratory Biomarker Analysis: Correlative studies Tivantinib: Given PO
Blood and lymphatic system disorders Anemia	40.0% 10/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	28.0% 7/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Cardiac disorders Sinus bradycardia	8.0% 2/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	16.0% 4/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Gastrointestinal disorders Abdominal pain	16.0% 4/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	16.0% 4/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Gastrointestinal disorders Bloating	12.0% 3/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	0.00% 0/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Gastrointestinal disorders Constipation	20.0% 5/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	16.0% 4/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Gastrointestinal disorders Diarrhea	16.0% 4/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	36.0% 9/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Gastrointestinal disorders Flatulence	4.0% 1/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	12.0% 3/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Gastrointestinal disorders Gastroesophageal reflux disease	8.0% 2/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	4.0% 1/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Gastrointestinal disorders Gastrointestinal disorders-Other	8.0% 2/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	0.00% 0/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Gastrointestinal disorders Mucositis oral	4.0% 1/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	8.0% 2/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Gastrointestinal disorders Nausea	44.0% 11/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	56.0% 14/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Gastrointestinal disorders Vomiting	12.0% 3/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	24.0% 6/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
General disorders Chills	8.0% 2/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	0.00% 0/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
General disorders Edema limbs	20.0% 5/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	4.0% 1/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
General disorders Fatigue	52.0% 13/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	52.0% 13/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
General disorders Fever	16.0% 4/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	16.0% 4/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
General disorders Flu like symptoms	0.00% 0/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	8.0% 2/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
General disorders Localized edema	4.0% 1/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	8.0% 2/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
General disorders Non-cardiac chest pain	8.0% 2/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	4.0% 1/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
General disorders Pain	16.0% 4/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	8.0% 2/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Infections and infestations Upper respiratory infection	8.0% 2/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	4.0% 1/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Investigations Alanine aminotransferase increased	8.0% 2/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	20.0% 5/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Investigations Alkaline phosphatase increased	12.0% 3/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	16.0% 4/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Investigations Aspartate aminotransferase increased	12.0% 3/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	20.0% 5/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Investigations Blood bilirubin increased	0.00% 0/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	12.0% 3/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Investigations Creatinine increased	24.0% 6/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	24.0% 6/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Investigations Lymphocyte count decreased	16.0% 4/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	32.0% 8/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Investigations Neutrophil count decreased	8.0% 2/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	0.00% 0/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Investigations Weight gain	12.0% 3/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	8.0% 2/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Investigations Weight loss	8.0% 2/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	20.0% 5/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Investigations White blood cell decreased	12.0% 3/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	8.0% 2/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Metabolism and nutrition disorders Anorexia	16.0% 4/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	32.0% 8/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Metabolism and nutrition disorders Hyperglycemia	28.0% 7/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	32.0% 8/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Metabolism and nutrition disorders Hyperkalemia	8.0% 2/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	12.0% 3/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Metabolism and nutrition disorders Hypoalbuminemia	16.0% 4/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	16.0% 4/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Metabolism and nutrition disorders Hypocalcemia	4.0% 1/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	12.0% 3/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Metabolism and nutrition disorders Hypokalemia	8.0% 2/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	8.0% 2/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Metabolism and nutrition disorders Hyponatremia	12.0% 3/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	16.0% 4/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Musculoskeletal and connective tissue disorders Back pain	16.0% 4/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	4.0% 1/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Musculoskeletal and connective tissue disorders Chest wall pain	8.0% 2/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	0.00% 0/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Musculoskeletal and connective tissue disorders Flank pain	8.0% 2/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	0.00% 0/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Musculoskeletal and connective tissue disorders Myalgia	8.0% 2/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	0.00% 0/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Musculoskeletal and connective tissue disorders Pain in extremity	20.0% 5/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	4.0% 1/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Nervous system disorders Dizziness	8.0% 2/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	4.0% 1/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Nervous system disorders Dysgeusia	8.0% 2/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	16.0% 4/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Nervous system disorders Headache	8.0% 2/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	8.0% 2/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Nervous system disorders Peripheral sensory neuropathy	12.0% 3/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	4.0% 1/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Psychiatric disorders Anxiety	8.0% 2/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	0.00% 0/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Psychiatric disorders Depression	8.0% 2/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	4.0% 1/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Psychiatric disorders Insomnia	12.0% 3/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	0.00% 0/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Renal and urinary disorders Hematuria	0.00% 0/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	8.0% 2/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Renal and urinary disorders Proteinuria	0.00% 0/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	8.0% 2/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Respiratory, thoracic and mediastinal disorders Cough	20.0% 5/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	20.0% 5/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Respiratory, thoracic and mediastinal disorders Dyspnea	12.0% 3/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	20.0% 5/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Skin and subcutaneous tissue disorders Alopecia	20.0% 5/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	8.0% 2/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Skin and subcutaneous tissue disorders Dry skin	4.0% 1/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	12.0% 3/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Skin and subcutaneous tissue disorders Erythema multiforme	0.00% 0/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	8.0% 2/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	8.0% 2/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Skin and subcutaneous tissue disorders Rash acneiform	0.00% 0/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	52.0% 13/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Skin and subcutaneous tissue disorders Rash maculo-papular	12.0% 3/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	12.0% 3/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Vascular disorders Hypertension	16.0% 4/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	24.0% 6/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.
Vascular disorders Hypotension	8.0% 2/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.	0.00% 0/25 • Up to 3 years This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment. Adverse events and all-cause mortality is reported for all eligible patients.

Additional Information

Przemyslaw W. Twardowski, MD

City of Hope National Medical Center

Phone: 626-256-4673

Email: ptwardowski@coh.org

Results disclosure agreements

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

Restriction type: LTE60