Trial Outcomes & Findings for Ficlatuzumab w/wo Cetuximab in Patients w/Cetuximab-Resistant, Recurrent or Metastatic Head/Neck Squamous Cell Carcinoma (NCT NCT03422536)

NCT ID: NCT03422536

Last Updated: 2024-09-04

Results Overview

Will be estimated for each arm using a Kaplan-Meier curve.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

78 participants

Primary outcome timeframe

From the date of randomization until the date of progression or death, assessed up to 2 years

Results posted on

2024-09-04

Participant Flow

This multicenter study was conducted at the University of Arizona, Emory University, Fox Chase Cancer Center, Medical University of South Carolina, Yale Cancer Center, and Moffitt Cancer Center. The study opened to accrual on 12/05/2017 and closed to accrual on 12/05/2020. Potential patients were identified in the cancer center clinic by study investigators or referred. Weekly tumor board meetings are held at each institution where patients are discussed and referred to clinical trials.

Of the 78 patients who signed consent, only 60 were randomized. 18 patients were excluded, 15 were determined to be ineligible after the screening period and 3 declined to participate after signing consent.

Participant milestones

Participant milestones
Measure	Arm I (Ficlatuzumab) Patients receive ficlatuzumab IV over 30-60 minutes every 2 weeks in the absence of disease progression or unaccepted toxicity. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Ficlatuzumab: Given IV	Arm II (Ficlatuzumab, Cetuximab) Patients receive cetuximab IV over 60 -120 minutes and ficlatuzumab IV over 30-60 minutes every 2 weeks in the absence of disease progression or unaccepted toxicity. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cetuximab: Given IV Ficlatuzumab: Given IV
Randomized STARTED	27	33
Randomized COMPLETED	26	32
Randomized NOT COMPLETED	1	1
Allocation - Received Intervention STARTED	26	32
Allocation - Received Intervention COMPLETED	0	1
Allocation - Received Intervention NOT COMPLETED	26	31

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm I (Ficlatuzumab) Patients receive ficlatuzumab IV over 30-60 minutes every 2 weeks in the absence of disease progression or unaccepted toxicity. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Ficlatuzumab: Given IV	Arm II (Ficlatuzumab, Cetuximab) Patients receive cetuximab IV over 60 -120 minutes and ficlatuzumab IV over 30-60 minutes every 2 weeks in the absence of disease progression or unaccepted toxicity. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cetuximab: Given IV Ficlatuzumab: Given IV
Randomized Physician Decision	1	1
Allocation - Received Intervention Disease progression	19	25
Allocation - Received Intervention Death	1	3
Allocation - Received Intervention Adverse Event	1	0
Allocation - Received Intervention Physician Decision	1	1
Allocation - Received Intervention Withdrawal by Subject	3	2
Allocation - Received Intervention Lost to Follow-up	1	0

Baseline Characteristics

Ficlatuzumab w/wo Cetuximab in Patients w/Cetuximab-Resistant, Recurrent or Metastatic Head/Neck Squamous Cell Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (Ficlatuzumab) n=27 Participants Patients receive ficlatuzumab IV over 30-60 minutes every 2 weeks in the absence of disease progression or unaccepted toxicity. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Ficlatuzumab: Given IV	Arm II (Ficlatuzumab, Cetuximab) n=33 Participants Patients receive cetuximab IV over 60 -120 minutes and ficlatuzumab IV over 30-60 minutes every 2 weeks in the absence of disease progression or unaccepted toxicity. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cetuximab: Given IV Ficlatuzumab: Given IV	Total n=60 Participants Total of all reporting groups
Age, Continuous	65 years n=5 Participants	63 years n=7 Participants	63.5 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	30 Participants n=7 Participants	51 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants n=5 Participants	29 Participants n=7 Participants	52 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	24 Participants n=5 Participants	30 Participants n=7 Participants	54 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	27 participants n=5 Participants	33 participants n=7 Participants	60 participants n=5 Participants
Primary Site Oral Cavity	8 participants n=5 Participants	6 participants n=7 Participants	14 participants n=5 Participants
Primary Site Oropharynx	11 participants n=5 Participants	20 participants n=7 Participants	31 participants n=5 Participants
Primary Site Larynx	3 participants n=5 Participants	4 participants n=7 Participants	7 participants n=5 Participants
Primary Site Nasopharynx	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants
Primary Site Paranasal sinus	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants
Primary Site External auditory canal	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Primary Site Unknown primary	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
HPV status Positive	11 participants n=5 Participants	17 participants n=7 Participants	28 participants n=5 Participants
HPV status Negative	16 participants n=5 Participants	16 participants n=7 Participants	32 participants n=5 Participants
Median months since last cetuximab treatment	2.7 Months n=5 Participants	3.6 Months n=7 Participants	3.5 Months n=5 Participants
History of platinum	27 participants n=5 Participants	32 participants n=7 Participants	59 participants n=5 Participants
History of anti-PD-1 (checkpoint protein) monoclonal antibody (mAb) treatment	25 participants n=5 Participants	31 participants n=7 Participants	56 participants n=5 Participants
Eastern Cooperative Oncology Group Performance Status (ECOG- PS) Asymptomatic (0) - Fully active, able to carry on all pre-disease performance without restriction	9 participants n=5 Participants	6 participants n=7 Participants	15 participants n=5 Participants
Eastern Cooperative Oncology Group Performance Status (ECOG- PS) Symptomatic (1) - restricted in physically strenuous activity but able to carry out light work	18 participants n=5 Participants	27 participants n=7 Participants	45 participants n=5 Participants

PRIMARY outcome

Timeframe: From the date of randomization until the date of progression or death, assessed up to 2 years

Will be estimated for each arm using a Kaplan-Meier curve.

Outcome measures

Outcome measures
Measure	Arm I (Ficlatuzumab) n=26 Participants Patients receive ficlatuzumab IV over 30-60 minutes every 2 weeks in the absence of disease progression or unaccepted toxicity. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Ficlatuzumab: Given IV	Arm II (Ficlatuzumab, Cetuximab) n=32 Participants Patients receive cetuximab IV over 60 -120 minutes and ficlatuzumab IV over 30-60 minutes every 2 weeks in the absence of disease progression or unaccepted toxicity. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cetuximab: Given IV Ficlatuzumab: Given IV
Progression Free Survival (PFS)	1.8 months Interval 1.7 to The Upper Confidence Interval was not computable as 50% of the group had not reached median PFS.	3.7 months Interval 2.3 to The Upper Confidence Interval was not computable as 50% of the group had not reached median PFS.

SECONDARY outcome

Timeframe: Up to 2 years

Population: The most common AEs are notated below.

The percentage of participants with dose limiting toxicities in each dosing cohort will be reported, as will the percentage of participants with adverse events in accordance with National Cancer Institute Common Terminology Criteria for Adverse Events version 4 grading criteria. Will be tabulated and reported with 95% exact confidence intervals.

Outcome measures

Outcome measures
Measure	Arm I (Ficlatuzumab) n=26 Participants Patients receive ficlatuzumab IV over 30-60 minutes every 2 weeks in the absence of disease progression or unaccepted toxicity. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Ficlatuzumab: Given IV	Arm II (Ficlatuzumab, Cetuximab) n=32 Participants Patients receive cetuximab IV over 60 -120 minutes and ficlatuzumab IV over 30-60 minutes every 2 weeks in the absence of disease progression or unaccepted toxicity. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cetuximab: Given IV Ficlatuzumab: Given IV
Percentage of Participants With Dose Limiting Toxicities or Adverse Events hypoalbuminemia	66 percentage of participants	76 percentage of participants
Percentage of Participants With Dose Limiting Toxicities or Adverse Events Edema	25 percentage of participants	44 percentage of participants
Percentage of Participants With Dose Limiting Toxicities or Adverse Events Acneiform rash	12 percentage of participants	82 percentage of participants
Percentage of Participants With Dose Limiting Toxicities or Adverse Events Pneumonitis	8 percentage of participants	3 percentage of participants

SECONDARY outcome

Timeframe: From the date of randomization until the date of death, assessed up to 2 years

Will be estimated for each arm using a Kaplan-Meier curve.

Outcome measures

Outcome measures
Measure	Arm I (Ficlatuzumab) n=26 Participants Patients receive ficlatuzumab IV over 30-60 minutes every 2 weeks in the absence of disease progression or unaccepted toxicity. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Ficlatuzumab: Given IV	Arm II (Ficlatuzumab, Cetuximab) n=32 Participants Patients receive cetuximab IV over 60 -120 minutes and ficlatuzumab IV over 30-60 minutes every 2 weeks in the absence of disease progression or unaccepted toxicity. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cetuximab: Given IV Ficlatuzumab: Given IV
Overall Survival (OS)	6.4 months Interval 3.0 to Note: The upper confidence interval for the Median Overall Survival was not computable as 50% of the group did not reach median OS	7.4 months Interval 4.7 to Note: The upper confidence interval for the Median Overall Survival was not computable as 50% of the group did not reach median OS

SECONDARY outcome

Timeframe: Up to 2 years

Will be assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RESIST v1.1) for target lesions and assessed by CT/MRI w/ contrast: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), the regression of all Target lesions (the sum) by 30% with no progression of Non-targets or presence of new lesion; Overall Response (OR) = CR + PR. Will be tabulated and reported with 95% exact confidence intervals.

Outcome measures

Outcome measures
Measure	Arm I (Ficlatuzumab) n=26 Participants Patients receive ficlatuzumab IV over 30-60 minutes every 2 weeks in the absence of disease progression or unaccepted toxicity. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Ficlatuzumab: Given IV	Arm II (Ficlatuzumab, Cetuximab) n=32 Participants Patients receive cetuximab IV over 60 -120 minutes and ficlatuzumab IV over 30-60 minutes every 2 weeks in the absence of disease progression or unaccepted toxicity. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cetuximab: Given IV Ficlatuzumab: Given IV
Overall Response Rate (ORR)	1 Participants	6 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre-study (within 4 weeks of study registration) and Week 4, Cycle 2 of Intervention

Will be assessed by Foundation for the Accreditation of Cellular Therapy Head and Neck Questionnaire.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 2 years

Population: Exploratory biomarker analysis was only conducted for the combination arm. The monotherapy arm closed for futility. It would be costly and would not add value to study biomarkers in the setting of an inactive agent to perform analyses for the monotherapy arm thus the limited funds available for correlatives were allocated to the combination arm.

Will evaluate the relationship between clinical outcomes (progression free survival, response rate) and candidate tumoral biomarkers: Tumor HGF and cMET expression. The relationship with clinical response will be assessed.

Outcome measures

Outcome measures
Measure	Arm I (Ficlatuzumab) Patients receive ficlatuzumab IV over 30-60 minutes every 2 weeks in the absence of disease progression or unaccepted toxicity. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Ficlatuzumab: Given IV	Arm II (Ficlatuzumab, Cetuximab) n=26 Participants Patients receive cetuximab IV over 60 -120 minutes and ficlatuzumab IV over 30-60 minutes every 2 weeks in the absence of disease progression or unaccepted toxicity. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cetuximab: Given IV Ficlatuzumab: Given IV
Tumor Biomarker Analysis HPV-positive patients	—	13 Participants
Tumor Biomarker Analysis HPV-negative patients	—	13 Participants
Tumor Biomarker Analysis HGF - HPV-positive	—	13 Participants
Tumor Biomarker Analysis HGF - HPV-negative	—	13 Participants
Tumor Biomarker Analysis C-met positive in HPV-negative patients	—	9 Participants
Tumor Biomarker Analysis C-met positive in HPV-positive patients	—	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 2 years

To evaluate the relationship between clinical outcomes (Progression-Free Survival and Response Rate) and candidate genomic biomarkers: mutations in PIK3CA, PTEN, and HRAS

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 2 years

Will evaluate the relationship between clinical outcomes (progression free survival, response rate) and candidate peripheral biomarkers: peripheral serum biomarkers including HGF, soluble HGF, and IL6; peripheral lymphocyte populations. The relationship with clinical response will be assessed.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 2 years

Will evaluate the relationship between clinical outcomes (progression free survival, response rate) and candidate immune biomarkers: archived and baseline immune filtrate; tumor HPV status. The relationship with clinical response will be assessed.

Outcome measures

Outcome data not reported

Adverse Events

Arm I (Ficlatuzumab)

Serious events: 7 serious events

Other events: 24 other events

Deaths: 1 deaths

Arm II (Ficlatuzumab, Cetuximab)

Serious events: 18 serious events

Other events: 31 other events

Deaths: 3 deaths

Serious adverse events

Other adverse events

Additional Information

Rachel Jarrett

University of Arizona Cancer Center

Phone: 5206260375

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Arm I (Ficlatuzumab) n=26 participants at risk Patients receive ficlatuzumab IV over 30-60 minutes every 2 weeks in the absence of disease progression or unaccepted toxicity. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Ficlatuzumab: Given IV	Arm II (Ficlatuzumab, Cetuximab) n=32 participants at risk Patients receive cetuximab IV over 60 -120 minutes and ficlatuzumab IV over 30-60 minutes every 2 weeks in the absence of disease progression or unaccepted toxicity. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cetuximab: Given IV Ficlatuzumab: Given IV
Respiratory, thoracic and mediastinal disorders Pharyngeal Hemorrhage	3.8% 1/26 • Number of events 3 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia	0.00% 0/32 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia
Nervous system disorders Encephalopathy	3.8% 1/26 • Number of events 1 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia	0.00% 0/32 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia
General disorders Facial edema	3.8% 1/26 • Number of events 1 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia	0.00% 0/32 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia
General disorders Limb edema	3.8% 1/26 • Number of events 1 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia	0.00% 0/32 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia
Respiratory, thoracic and mediastinal disorders Pleural effusion	3.8% 1/26 • Number of events 1 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia	0.00% 0/32 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia
Respiratory, thoracic and mediastinal disorders Pneumonitis	7.7% 2/26 • Number of events 2 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia	0.00% 0/32 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia
Vascular disorders Thromboembolic event	3.8% 1/26 • Number of events 1 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia	6.2% 2/32 • Number of events 2 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia
Gastrointestinal disorders Oral Cavity Hemmorhage	0.00% 0/26 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia	3.1% 1/32 • Number of events 1 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/26 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia	3.1% 1/32 • Number of events 1 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia
Infections and infestations Skin and soft tissue infection	0.00% 0/26 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia	6.2% 2/32 • Number of events 2 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia
Infections and infestations Lung infection	0.00% 0/26 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia	12.5% 4/32 • Number of events 4 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia
Respiratory, thoracic and mediastinal disorders Bronchial obstruction	0.00% 0/26 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia	3.1% 1/32 • Number of events 1 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia
Infections and infestations Genitourinary infection	0.00% 0/26 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia	3.1% 1/32 • Number of events 1 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia
Infections and infestations Bacteremia	0.00% 0/26 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia	9.4% 3/32 • Number of events 3 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia
Injury, poisoning and procedural complications Fall	0.00% 0/26 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia	6.2% 2/32 • Number of events 2 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia
Injury, poisoning and procedural complications Fracture	0.00% 0/26 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia	3.1% 1/32 • Number of events 1 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia
Cardiac disorders Mitral Regurgitation	0.00% 0/26 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia	3.1% 1/32 • Number of events 1 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia
Cardiac disorders Myocardial infarction	0.00% 0/26 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia	3.1% 1/32 • Number of events 1 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia
Metabolism and nutrition disorders Dehydration	0.00% 0/26 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia	3.1% 1/32 • Number of events 1 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia
Gastrointestinal disorders Dysphagia	0.00% 0/26 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia	6.2% 2/32 • Number of events 2 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia
Gastrointestinal disorders Abdominal pain	0.00% 0/26 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia	6.2% 2/32 • Number of events 2 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia
Gastrointestinal disorders Dyspepsia	0.00% 0/26 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia	3.1% 1/32 • Number of events 1 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia
Nervous system disorders Syncope	0.00% 0/26 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia	3.1% 1/32 • Number of events 1 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/26 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia	3.1% 1/32 • Number of events 1 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/26 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia	6.2% 2/32 • Number of events 2 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia

Other adverse events
Measure	Arm I (Ficlatuzumab) n=26 participants at risk Patients receive ficlatuzumab IV over 30-60 minutes every 2 weeks in the absence of disease progression or unaccepted toxicity. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Ficlatuzumab: Given IV	Arm II (Ficlatuzumab, Cetuximab) n=32 participants at risk Patients receive cetuximab IV over 60 -120 minutes and ficlatuzumab IV over 30-60 minutes every 2 weeks in the absence of disease progression or unaccepted toxicity. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cetuximab: Given IV Ficlatuzumab: Given IV
Infections and infestations Oral infection	11.5% 3/26 • Number of events 3 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia	6.2% 2/32 • Number of events 2 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia
General disorders Facial Edema	19.2% 5/26 • Number of events 5 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia	12.5% 4/32 • Number of events 4 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia
General disorders Edema limbs	38.5% 10/26 • Number of events 10 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia	43.8% 14/32 • Number of events 14 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia
Metabolism and nutrition disorders Hypoalbumenia	65.4% 17/26 • Number of events 17 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia	75.0% 24/32 • Number of events 24 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia
Metabolism and nutrition disorders Hyponatremia	7.7% 2/26 • Number of events 2 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia	3.1% 1/32 • Number of events 1 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia
Blood and lymphatic system disorders Anemia	7.7% 2/26 • Number of events 2 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia	9.4% 3/32 • Number of events 3 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia
Cardiac disorders Hypotension	7.7% 2/26 • Number of events 2 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia	0.00% 0/32 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia
General disorders Fatigue	7.7% 2/26 • Number of events 2 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia	12.5% 4/32 • Number of events 4 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia
Skin and subcutaneous tissue disorders Rash: Maculopapular	11.5% 3/26 • Number of events 3 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia	3.1% 1/32 • Number of events 14 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia
Skin and subcutaneous tissue disorders Rash: acneiform	7.7% 2/26 • Number of events 2 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia	81.2% 26/32 • Number of events 26 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia
Gastrointestinal disorders Diarrhea	3.8% 1/26 • Number of events 1 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia	21.9% 7/32 • Number of events 7 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia
Gastrointestinal disorders Dysphagia	3.8% 1/26 • Number of events 1 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia	6.2% 2/32 • Number of events 2 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia
Respiratory, thoracic and mediastinal disorders Dyspnea	7.7% 2/26 • Number of events 2 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia	12.5% 4/32 • Number of events 5 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia
Respiratory, thoracic and mediastinal disorders Pleural effusion	7.7% 2/26 • Number of events 2 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia	3.1% 1/32 • Number of events 1 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia
Vascular disorders Thromboembolic event	7.7% 2/26 • Number of events 2 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia	6.2% 2/32 • Number of events 2 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia
Infections and infestations Bacteremia	0.00% 0/26 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia	9.4% 3/32 • Number of events 3 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia
Infections and infestations Skin infection	0.00% 0/26 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia	18.8% 6/32 • Number of events 6 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia
Infections and infestations Genitourinary infection	0.00% 0/26 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia	9.4% 3/32 • Number of events 3 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia
Respiratory, thoracic and mediastinal disorders Lung infection	0.00% 0/26 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia	9.4% 3/32 • Number of events 3 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia
Investigations Increased AST and/or ALT	0.00% 0/26 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia	6.2% 2/32 • Number of events 2 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia
Metabolism and nutrition disorders Hypomagnesemia	0.00% 0/26 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia	9.4% 3/32 • Number of events 3 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia
Metabolism and nutrition disorders Hypokalemia	0.00% 0/26 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia	12.5% 4/32 • Number of events 4 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia
Injury, poisoning and procedural complications Fracture	0.00% 0/26 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia	6.2% 2/32 • Number of events 2 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia
Psychiatric disorders Insomnia	0.00% 0/26 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia	6.2% 2/32 • Number of events 2 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia
Investigations Weight loss	0.00% 0/26 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia	9.4% 3/32 • Number of events 3 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia
Metabolism and nutrition disorders Anorexia	0.00% 0/26 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia	9.4% 3/32 • Number of events 3 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia
Gastrointestinal disorders Constipation	0.00% 0/26 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia	9.4% 3/32 • Number of events 3 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia
Metabolism and nutrition disorders Dehydration	0.00% 0/26 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia	6.2% 2/32 • Number of events 2 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia
Gastrointestinal disorders Oral mucositis	0.00% 0/26 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia	9.4% 3/32 • Number of events 3 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia
Gastrointestinal disorders Vomiting	0.00% 0/26 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia	6.2% 2/32 • Number of events 2 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia
Nervous system disorders Headache	3.8% 1/26 • Number of events 1 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia	12.5% 4/32 • Number of events 4 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia
Musculoskeletal and connective tissue disorders Musculoskeletal pain	3.8% 1/26 • Number of events 1 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia	15.6% 5/32 • Number of events 5 • Adverse events (AEs) were collected staring at Cycle1 Day1 and continued at each study visit during the treatment phase. I.e., day 1 and day 15 of each 28-day cycle, and any unplanned visits. Subjects are followed for AEs for at least 60 days after the last dose of study drug(s) or until the initiation of subsequent antineoplastic therapy, whichever is earlier, up to 2 years. During the 60-day follow up, AEs are assessed at each scheduled follow-up visit, and any unplanned contacts. Only AEs meeting one of the below criteria were collected: * Any AE that is Grade 3 or \> * Any AE that results in submission of a serious adverse event(SAE) * Any intolerable Grade 2 AE * Any Grade AE resulting in a dose reduction of study drugs * Any Grade 2 laboratory or vital sign values that are deemed clinically significant by the treating investigator * Any Grade AE in the following categories: * Rash * Diarrhea * Edema, peripheral * Edema, head, face and neck * Hypoalbuminemia