Trial Outcomes & Findings for BATTLE-FL: Front-Line Biomarker-Integrated Treatment Study in Non Small Cell Lung Cancer (NCT NCT01263782)

NCT ID: NCT01263782

Last Updated: 2019-05-15

Results Overview

It is defined as from treatment start to the time of progression or death, whichever occurred first, or to the time of last contact. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 64 participants
• Primary outcome timeframe: From treatment start to the time of progression or death, whichever occurred first, or to the time of last contact, assessed up to 5 years
• Results posted on: 2019-05-15

Participant Flow

Twenty-four patients with non-small cell lung cancer were recruited from June 2011 to October 2013 at the University of Texas MD Anderson Cancer Center.

The patients had pre-treatment evaluations, which were used to determine the patients' study eligibility, within 4 weeks prior to initiating therapy. Out of 64 participants, 40 was screen failed.

Participant milestones

Measure	Carboplatin + Pemetrexed x 4 Cycles Followed by Maintenance Pe Four 21-day cycles of combination AUC 6 of carboplatin and 500 mg/m2 of pemetrexed; maintenance pemetrexed and pemetrexed every 21 days until disease progression	Carboplatin + Pemetrexed + Bevacizumab Followed by Maintenance Four 21-day cycles of combination AUC 6 of carboplatin, 500 mg/m2 of pemetrexed, and 15 mg/kg of bevacizumab; maintenance pemetrexed and bevacizumab every 21 days until disease progression	Carboplatin + Pemetrexed + Cetuximab Followed by Maintenance P Four 21-day cycles of combination AUC 6 of carboplatin, 500 mg/m2 of pemetrexed, and 250 mg/m2 of cetuximab (400mg/m2 on Cycle 1, Day 1 only); maintenance pemetrexed and cetuximab every 21 days until disease progression	Carboplatin + Pemetrexed + Cixutumumab Followed by Maintenance Four 21-day cycles of combination AUC 6 of carboplatin, 500 mg/m2 of pemetrexed, and 20 mg/kg of cixutumumab; maintenance pemetrexed and cixutumumab every 21 days until disease progression
Overall Study STARTED	6	6	6	6
Overall Study COMPLETED	6	6	3	5
Overall Study NOT COMPLETED	0	0	3	1

Reasons for withdrawal

Measure	Carboplatin + Pemetrexed x 4 Cycles Followed by Maintenance Pe Four 21-day cycles of combination AUC 6 of carboplatin and 500 mg/m2 of pemetrexed; maintenance pemetrexed and pemetrexed every 21 days until disease progression	Carboplatin + Pemetrexed + Bevacizumab Followed by Maintenance Four 21-day cycles of combination AUC 6 of carboplatin, 500 mg/m2 of pemetrexed, and 15 mg/kg of bevacizumab; maintenance pemetrexed and bevacizumab every 21 days until disease progression	Carboplatin + Pemetrexed + Cetuximab Followed by Maintenance P Four 21-day cycles of combination AUC 6 of carboplatin, 500 mg/m2 of pemetrexed, and 250 mg/m2 of cetuximab (400mg/m2 on Cycle 1, Day 1 only); maintenance pemetrexed and cetuximab every 21 days until disease progression	Carboplatin + Pemetrexed + Cixutumumab Followed by Maintenance Four 21-day cycles of combination AUC 6 of carboplatin, 500 mg/m2 of pemetrexed, and 20 mg/kg of cixutumumab; maintenance pemetrexed and cixutumumab every 21 days until disease progression
Overall Study Death	0	0	1	0
Overall Study Progressive disease	0	0	0	1
Overall Study Too early	0	0	1	0
Overall Study Inevaluable	0	0	1	0

Baseline Characteristics

BATTLE-FL: Front-Line Biomarker-Integrated Treatment Study in Non Small Cell Lung Cancer

Baseline characteristics by cohort

Measure	Carboplatin + Pemetrexed x 4 Cycles Followed by Maintenance Pe n=6 Participants Four 21-day cycles of combination AUC 6 of carboplatin and 500 mg/m2 of pemetrexed; maintenance pemetrexed and pemetrexed every 21 days until disease progression	Carboplatin + Pemetrexed + Bevacizumab Followed by Maintenance n=6 Participants Four 21-day cycles of combination AUC 6 of carboplatin, 500 mg/m2 of pemetrexed, and 15 mg/kg of bevacizumab; maintenance pemetrexed and bevacizumab every 21 days until disease progression	Carboplatin + Pemetrexed + Cetuximab Followed by Maintenance P n=6 Participants Four 21-day cycles of combination AUC 6 of carboplatin, 500 mg/m2 of pemetrexed, and 250 mg/m2 of cetuximab (400mg/m2 on Cycle 1, Day 1 only); maintenance pemetrexed and cetuximab every 21 days until disease progression	Carboplatin + Pemetrexed + Cixutumumab Followed by Maintenance n=6 Participants Four 21-day cycles of combination AUC 6 of carboplatin, 500 mg/m2 of pemetrexed, and 20 mg/kg of cixutumumab; maintenance pemetrexed and cixutumumab every 21 days until disease progression	Total n=24 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	11 Participants n=21 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	13 Participants n=21 Participants
Age, Continuous	66 years n=5 Participants	65 years n=7 Participants	68 years n=5 Participants	68 years n=4 Participants	66 years n=21 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	7 Participants n=21 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants	17 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	21 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 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	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	4 Participants n=4 Participants	19 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment United States	6 participants n=5 Participants	6 participants n=7 Participants	6 participants n=5 Participants	6 participants n=4 Participants	24 participants n=21 Participants

PRIMARY outcome

Timeframe: From treatment start to the time of progression or death, whichever occurred first, or to the time of last contact, assessed up to 5 years

Population: Patients who had treatment

It is defined as from treatment start to the time of progression or death, whichever occurred first, or to the time of last contact. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Outcome measures

Measure	Carboplatin + Pemetrexed x 4 Cycles Followed by Maintenance Pe n=6 Participants Four 21-day cycles of combination AUC 6 of carboplatin and 500 mg/m2 of pemetrexed; maintenance pemetrexed and pemetrexed every 21 days until disease progression	Carboplatin + Pemetrexed + Bevacizumab Followed by Maintenance n=6 Participants Four 21-day cycles of combination AUC 6 of carboplatin, 500 mg/m2 of pemetrexed, and 15 mg/kg of bevacizumab; maintenance pemetrexed and bevacizumab every 21 days until disease progression	Carboplatin + Pemetrexed + Cetuximab Followed by Maintenance P n=6 Participants Four 21-day cycles of combination AUC 6 of carboplatin, 500 mg/m2 of pemetrexed, and 250 mg/m2 of cetuximab (400mg/m2 on Cycle 1, Day 1 only); maintenance pemetrexed and cetuximab every 21 days until disease progression	Carboplatin + Pemetrexed + Cixutumumab Followed by Maintenance n=6 Participants Four 21-day cycles of combination AUC 6 of carboplatin, 500 mg/m2 of pemetrexed, and 20 mg/kg of cixutumumab; maintenance pemetrexed and cixutumumab every 21 days until disease progression
Progression Free Survival	5.2 month Interval 1.3 to 11.2	14.5 month Interval 1.5 to 53.7	20.6 month Interval 1.4 to 26.0	8 month Interval 3.2 to 22.09

SECONDARY outcome

Timeframe: From treatment start to every two cycles of completed therapy.

Population: Patients who were evaluable for response

Tumor response was assessed every two cycles of completed therapy. Responses will be based on a comparison to the pretreatment tumor evaluation. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Outcome measures

Measure	Carboplatin + Pemetrexed x 4 Cycles Followed by Maintenance Pe n=6 Participants Four 21-day cycles of combination AUC 6 of carboplatin and 500 mg/m2 of pemetrexed; maintenance pemetrexed and pemetrexed every 21 days until disease progression	Carboplatin + Pemetrexed + Bevacizumab Followed by Maintenance n=6 Participants Four 21-day cycles of combination AUC 6 of carboplatin, 500 mg/m2 of pemetrexed, and 15 mg/kg of bevacizumab; maintenance pemetrexed and bevacizumab every 21 days until disease progression	Carboplatin + Pemetrexed + Cetuximab Followed by Maintenance P n=6 Participants Four 21-day cycles of combination AUC 6 of carboplatin, 500 mg/m2 of pemetrexed, and 250 mg/m2 of cetuximab (400mg/m2 on Cycle 1, Day 1 only); maintenance pemetrexed and cetuximab every 21 days until disease progression	Carboplatin + Pemetrexed + Cixutumumab Followed by Maintenance n=6 Participants Four 21-day cycles of combination AUC 6 of carboplatin, 500 mg/m2 of pemetrexed, and 20 mg/kg of cixutumumab; maintenance pemetrexed and cixutumumab every 21 days until disease progression
Overall Response Rate No change/Stable Disease	5 Participants	3 Participants	2 Participants	3 Participants
Overall Response Rate Partial Remission	0 Participants	3 Participants	1 Participants	2 Participants
Overall Response Rate Progressive Disease	1 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

Carboplatin + Pemetrexed x 4 Cycles Followed by Maintenance Pe

Serious events: 2 serious events

Other events: 6 other events

Deaths: 1 deaths

Carboplatin + Pemetrexed + Bevacizumab Followed by Maintenance

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Carboplatin + Pemetrexed + Cetuximab Followed by Maintenance P

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Carboplatin + Pemetrexed + Cixutumumab Followed by Maintenance

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	Carboplatin + Pemetrexed x 4 Cycles Followed by Maintenance Pe n=6 participants at risk Four 21-day cycles of combination AUC 6 of carboplatin and 500 mg/m2 of pemetrexed; maintenance pemetrexed and pemetrexed every 21 days until disease progression	Carboplatin + Pemetrexed + Bevacizumab Followed by Maintenance n=6 participants at risk Four 21-day cycles of combination AUC 6 of carboplatin, 500 mg/m2 of pemetrexed, and 15 mg/kg of bevacizumab; maintenance pemetrexed and bevacizumab every 21 days until disease progression	Carboplatin + Pemetrexed + Cetuximab Followed by Maintenance P n=3 participants at risk Four 21-day cycles of combination AUC 6 of carboplatin, 500 mg/m2 of pemetrexed, and 250 mg/m2 of cetuximab (400mg/m2 on Cycle 1, Day 1 only); maintenance pemetrexed and cetuximab every 21 days until disease progression	Carboplatin + Pemetrexed + Cixutumumab Followed by Maintenance n=5 participants at risk Four 21-day cycles of combination AUC 6 of carboplatin, 500 mg/m2 of pemetrexed, and 20 mg/kg of cixutumumab; maintenance pemetrexed and cixutumumab every 21 days until disease progression
Cardiac disorders Cardiac arrest	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Investigations Creatinine increased	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	33.3% 1/3 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Metabolism and nutrition disorders Hypercalcemia	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	33.3% 1/3 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Metabolism and nutrition disorders Hyperglycemia	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Respiratory, thoracic and mediastinal disorders Pneumonitis	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Infections and infestations Sepsis	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Surgical and medical procedures Other, Endarterectomy	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	33.3% 1/3 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Infections and infestations Urinary tract infection	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.

Other adverse events

Measure	Carboplatin + Pemetrexed x 4 Cycles Followed by Maintenance Pe n=6 participants at risk Four 21-day cycles of combination AUC 6 of carboplatin and 500 mg/m2 of pemetrexed; maintenance pemetrexed and pemetrexed every 21 days until disease progression	Carboplatin + Pemetrexed + Bevacizumab Followed by Maintenance n=6 participants at risk Four 21-day cycles of combination AUC 6 of carboplatin, 500 mg/m2 of pemetrexed, and 15 mg/kg of bevacizumab; maintenance pemetrexed and bevacizumab every 21 days until disease progression	Carboplatin + Pemetrexed + Cetuximab Followed by Maintenance P n=3 participants at risk Four 21-day cycles of combination AUC 6 of carboplatin, 500 mg/m2 of pemetrexed, and 250 mg/m2 of cetuximab (400mg/m2 on Cycle 1, Day 1 only); maintenance pemetrexed and cetuximab every 21 days until disease progression	Carboplatin + Pemetrexed + Cixutumumab Followed by Maintenance n=5 participants at risk Four 21-day cycles of combination AUC 6 of carboplatin, 500 mg/m2 of pemetrexed, and 20 mg/kg of cixutumumab; maintenance pemetrexed and cixutumumab every 21 days until disease progression
Gastrointestinal disorders Abdominal pain	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	20.0% 1/5 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
General disorders Abrasions to RUE.	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Investigations Alanine aminotransferase increased	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	16.7% 1/6 • Number of events 2 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	20.0% 1/5 • Number of events 2 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Investigations Alkaline phosphatase increased	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	20.0% 1/5 • Number of events 2 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	20.0% 1/5 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Immune system disorders Anaphylaxis	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	33.3% 1/3 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Blood and lymphatic system disorders Anemia	50.0% 3/6 • Number of events 8 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	50.0% 3/6 • Number of events 6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	66.7% 2/3 • Number of events 6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	80.0% 4/5 • Number of events 8 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Metabolism and nutrition disorders Anorexia	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	33.3% 2/6 • Number of events 2 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	33.3% 1/3 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	60.0% 3/5 • Number of events 5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Psychiatric disorders Anxiety	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	33.3% 2/6 • Number of events 2 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	66.7% 2/3 • Number of events 2 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	40.0% 2/5 • Number of events 2 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Musculoskeletal and connective tissue disorders Arthralgia	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Investigations Aspartate aminotransferase increased	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	33.3% 1/3 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	20.0% 1/5 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	33.3% 1/3 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Gastrointestinal disorders Billary tract infection (cholendocholithiasis)	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Infections and infestations Bladder infection	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	20.0% 1/5 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	33.3% 1/3 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Investigations Blood bilirubin increased	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	20.0% 1/5 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Respiratory, thoracic and mediastinal disorders Bronchial obstruction	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	33.3% 1/3 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Cardiac disorders CAD	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Vascular disorders Carotid Stenosis, Rt. interval	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	33.3% 1/3 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Cardiac disorders Chest pain - cardiac	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Musculoskeletal and connective tissue disorders Chest wall pain	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Investigations Cholesterol high	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	33.3% 2/6 • Number of events 2 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	20.0% 1/5 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Renal and urinary disorders Chronic kidney disease	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	33.3% 1/3 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Gastrointestinal disorders Constipation	50.0% 3/6 • Number of events 3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	33.3% 2/6 • Number of events 2 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	33.3% 1/3 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	40.0% 2/5 • Number of events 2 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Respiratory, thoracic and mediastinal disorders Cough	83.3% 5/6 • Number of events 5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	33.3% 2/6 • Number of events 2 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	66.7% 2/3 • Number of events 2 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	20.0% 1/5 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Investigations Creatinine increased	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	33.3% 2/6 • Number of events 2 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	66.7% 2/3 • Number of events 4 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	20.0% 1/5 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Psychiatric disorders Depression	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	20.0% 1/5 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Gastrointestinal disorders Diarrhea	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	16.7% 1/6 • Number of events 2 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	33.3% 1/3 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	20.0% 1/5 • Number of events 3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Gastrointestinal disorders Diverticulosis	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Nervous system disorders Dizziness	16.7% 1/6 • Number of events 3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Gastrointestinal disorders Dry mouth	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	33.3% 1/3 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Nervous system disorders Dysesthesia	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Nervous system disorders Dysgeusia	16.7% 1/6 • Number of events 2 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	40.0% 2/5 • Number of events 2 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Gastrointestinal disorders Dyspepsia	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	33.3% 1/3 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Gastrointestinal disorders Dysphagia	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	16.7% 1/6 • Number of events 3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Respiratory, thoracic and mediastinal disorders Dyspnea	66.7% 4/6 • Number of events 8 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	66.7% 4/6 • Number of events 4 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	66.7% 2/3 • Number of events 2 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	40.0% 2/5 • Number of events 2 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Nervous system disorders Edema (Brain-cerebral)	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	20.0% 1/5 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
General disorders Edema face	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
General disorders Edema limbs	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	16.7% 1/6 • Number of events 2 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	66.7% 2/3 • Number of events 2 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	20.0% 1/5 • Number of events 3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
General disorders Edema trunk	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Investigations Elevated LDH	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	16.7% 1/6 • Number of events 2 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Skin and subcutaneous tissue disorders Erythema multiforme	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Gastrointestinal disorders Esophageal obstruction	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Gastrointestinal disorders Esophagitis	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
General disorders Fatigue	66.7% 4/6 • Number of events 5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	66.7% 4/6 • Number of events 4 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	100.0% 3/3 • Number of events 3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	80.0% 4/5 • Number of events 5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
General disorders Fever	50.0% 3/6 • Number of events 4 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	33.3% 1/3 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
General disorders Gait disturbance	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	20.0% 1/5 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Gastrointestinal disorders Gastroesophageal reflux disease	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	33.3% 2/6 • Number of events 2 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	33.3% 2/6 • Number of events 2 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	33.3% 1/3 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Renal and urinary disorders Glucosuria	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	20.0% 1/5 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Ear and labyrinth disorders Hearning Loss	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Investigations Hemoglobin increased	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	20.0% 1/5 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Renal and urinary disorders Hemoglobinuria	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	20.0% 1/5 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Respiratory, thoracic and mediastinal disorders Hemoptysis	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	33.3% 1/3 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Respiratory, thoracic and mediastinal disorders Hoarseness	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Metabolism and nutrition disorders Hypercalcemia	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	33.3% 1/3 • Number of events 3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Metabolism and nutrition disorders Hyperglycemia	33.3% 2/6 • Number of events 10 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	16.7% 1/6 • Number of events 3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	33.3% 1/3 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	60.0% 3/5 • Number of events 7 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Metabolism and nutrition disorders Hyperkalemia	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	33.3% 1/3 • Number of events 3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	20.0% 1/5 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Metabolism and nutrition disorders Hypernatremia	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Vascular disorders Hypertension	33.3% 2/6 • Number of events 2 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	33.3% 2/6 • Number of events 2 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	66.7% 2/3 • Number of events 2 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	20.0% 1/5 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Metabolism and nutrition disorders Hyperuricemia	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	20.0% 1/5 • Number of events 4 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Metabolism and nutrition disorders Hypoalbuminemia	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	40.0% 2/5 • Number of events 2 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	33.3% 1/3 • Number of events 5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	20.0% 1/5 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	40.0% 2/5 • Number of events 4 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Metabolism and nutrition disorders Hypomagnesemia	50.0% 3/6 • Number of events 6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	33.3% 2/6 • Number of events 2 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	100.0% 3/3 • Number of events 12 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	40.0% 2/5 • Number of events 2 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Metabolism and nutrition disorders Hyponatremia	16.7% 1/6 • Number of events 2 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	40.0% 2/5 • Number of events 2 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Respiratory, thoracic and mediastinal disorders Hypoxia	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	33.3% 1/3 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Metabolism and nutrition disorders Increasse LDH	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	20.0% 1/5 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
General disorders Infusion related reaction	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	33.3% 1/3 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Psychiatric disorders Insomnia	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	33.3% 1/3 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	60.0% 3/5 • Number of events 3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Psychiatric disorders Irritability, intermittent	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	20.0% 1/5 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Skin and subcutaneous tissue disorders itching	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Infections and infestations Laryngitis	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Infections and infestations Lung infection	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	33.3% 1/3 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Gastrointestinal disorders Mucositis oral	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	20.0% 1/5 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Musculoskeletal and connective tissue disorders Myalgia	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Cardiac disorders Myocardial infarction	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Gastrointestinal disorders Nausea	33.3% 2/6 • Number of events 3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	66.7% 4/6 • Number of events 4 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	33.3% 1/3 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	20.0% 1/5 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Investigations Neutrophil count decreased	16.7% 1/6 • Number of events 4 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	33.3% 2/6 • Number of events 3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	33.3% 1/3 • Number of events 2 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	20.0% 1/5 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Gastrointestinal disorders Oral pain	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
General disorders Pain	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	66.7% 4/6 • Number of events 4 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	33.3% 1/3 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	40.0% 2/5 • Number of events 2 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Infections and infestations Paronychia	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	33.3% 1/3 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Nervous system disorders Peripheral sensory neuropathy	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Investigations Platelet count decreased	16.7% 1/6 • Number of events 2 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	50.0% 3/6 • Number of events 4 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	33.3% 1/3 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	20.0% 1/5 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Respiratory, thoracic and mediastinal disorders Pleural effusion	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	20.0% 1/5 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Renal and urinary disorders Proteinuria	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	33.3% 2/6 • Number of events 6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	33.3% 1/3 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	20.0% 1/5 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Skin and subcutaneous tissue disorders Rash acneiform	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	66.7% 2/3 • Number of events 3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Renal and urinary disorders Renal hemorrhage	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	20.0% 1/5 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Respiratory, thoracic and mediastinal disorders Sore throat	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Nervous system disorders Stroke	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	33.3% 1/3 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Musculoskeletal and connective tissue disorders swelling both hands	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	33.3% 1/3 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	20.0% 1/5 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Vascular disorders Thromboembolic event	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	20.0% 1/5 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Nervous system disorders Tremor	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	20.0% 1/5 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Infections and infestations Upper respiratory infection	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	33.3% 1/3 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Renal and urinary disorders Urinary frequency	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	20.0% 1/5 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Renal and urinary disorders Urinary retention	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	20.0% 1/5 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Infections and infestations Urinary tract infection	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Renal and urinary disorders Urine discoloration	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	20.0% 1/5 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Infections and infestations Vaginal infection	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Gastrointestinal disorders Vomiting	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Eye disorders Watering eyes	16.7% 1/6 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/5 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Investigations Weight loss	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	33.3% 2/6 • Number of events 2 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	60.0% 3/5 • Number of events 3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.
Investigations White blood cell decreased	0.00% 0/6 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	33.3% 2/6 • Number of events 2 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	0.00% 0/3 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.	20.0% 1/5 • Number of events 1 • Through study completion, an average of 3 years Patients who were evaluable for toxicity and grades 1-3 adverse events.

Additional Information

Dr. George Simon, Thoracic/Head & Neck Med Onc

UT MD Anderson Cancer Center

Phone: 713-794-4740

Email: GSIMON@MDANDERSON.ORG

Results disclosure agreements

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