Trial Outcomes & Findings for Levocetirizine + Capecitabine + Bevacizumab for Patients With Refractory Colorectal Cancer (NCT NCT01722162)

NCT ID: NCT01722162

Last Updated: 2017-04-20

Results Overview

* Time from start of treatment to the time of progression or death, whichever occurs first * Progressive disease (target lesions): at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. * Progressive disease (non-target lesions): appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 47 participants
• Primary outcome timeframe: Until progressive disease (PD) (estimated to be 92 days)
• Results posted on: 2017-04-20

Participant Flow

The study opened to patient enrollment on 04/26/2013 and closed to patient enrollment on 07/15/2015.

Participant milestones

Measure	Arm A: (Start Levocetirizine After Bevacizumab/Capecitabine) Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle. Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle. Levocetirizine PO 5 mg daily before bed starting on Day 8 of Cycle 1. 5 mg daily before bed Days 1-4 of each cycle starting with cycle 2.	Arm B: (Start Levocetirizine Before Bevacizumab/Capecitabine) Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle. Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle. Levocetirizine PO 5 mg daily starting 7 days prior to initiation of bevacizumab and capecitabine therapy. 5 mg daily Days 1-14 starting with cycle 2.
Overall Study STARTED	23	24
Overall Study COMPLETED	18	18
Overall Study NOT COMPLETED	5	6

Reasons for withdrawal

Measure	Arm A: (Start Levocetirizine After Bevacizumab/Capecitabine) Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle. Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle. Levocetirizine PO 5 mg daily before bed starting on Day 8 of Cycle 1. 5 mg daily before bed Days 1-4 of each cycle starting with cycle 2.	Arm B: (Start Levocetirizine Before Bevacizumab/Capecitabine) Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle. Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle. Levocetirizine PO 5 mg daily starting 7 days prior to initiation of bevacizumab and capecitabine therapy. 5 mg daily Days 1-14 starting with cycle 2.
Overall Study Withdrawal by Subject	1	1
Overall Study Found ineligible	1	0
Overall Study Unrelated to study adverse event	2	2
Overall Study Adverse Event	1	1
Overall Study Insurance denial post enrollment	0	1
Overall Study Noncompliance	0	1

Baseline Characteristics

Levocetirizine + Capecitabine + Bevacizumab for Patients With Refractory Colorectal Cancer

Baseline characteristics by cohort

Measure	Arm A: (Start Levocetirizine After Bevacizumab/Capecitabine) n=23 Participants Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle. Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle. Levocetirizine PO 5 mg daily before bed starting on Day 8 of Cycle 1. 5 mg daily before bed Days 1-4 of each cycle starting with cycle 2.	Arm B: (Start Levocetirizine Before Bevacizumab/Capecitabine) n=24 Participants Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle. Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle. Levocetirizine PO 5 mg daily starting 7 days prior to initiation of bevacizumab and capecitabine therapy. 5 mg daily Days 1-14 starting with cycle 2.	Total n=47 Participants Total of all reporting groups
Age, Continuous	62 years n=5 Participants	57.5 years n=7 Participants	60 years n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	15 Participants n=7 Participants	29 Participants n=5 Participants
Region of Enrollment United States	23 participants n=5 Participants	24 participants n=7 Participants	47 participants n=5 Participants

PRIMARY outcome

Timeframe: Until progressive disease (PD) (estimated to be 92 days)

• Time from start of treatment to the time of progression or death, whichever occurs first
• Progressive disease (target lesions): at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
• Progressive disease (non-target lesions): appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.

Outcome measures

Measure	Arm A: (Start Levocetirizine After Bevacizumab/Capecitabine) n=18 Participants Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle. Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle. Levocetirizine PO 5 mg daily before bed starting on Day 8 of Cycle 1. 5 mg daily before bed Days 1-4 of each cycle starting with cycle 2.	Arm B: (Start Levocetirizine Before Bevacizumab/Capecitabine) Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle. Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle. Levocetirizine PO 5 mg daily starting 7 days prior to initiation of bevacizumab and capecitabine therapy. 5 mg daily Days 1-14 starting with cycle 2.
Progression Free Survival (Arm A) PFS Days = 29	0.946 proportion of patients with PFS Interval 0.848 to 1.0	—
Progression Free Survival (Arm A) PFS Days = 36	0.892 proportion of patients with PFS Interval 0.761 to 1.0	—
Progression Free Survival (Arm A) PFS Days = 43	0.739 proportion of patients with PFS Interval 0.567 to 0.964	—
Progression Free Survival (Arm A) PFS Days = 46	0.685 proportion of patients with PFS Interval 0.505 to 0.929	—
Progression Free Survival (Arm A) PFS Days = 50	0.630 proportion of patients with PFS Interval 0.446 to 0.89	—
Progression Free Survival (Arm A) PFS Days = 92	0.575 proportion of patients with PFS Interval 0.39 to 0.849	—

PRIMARY outcome

Timeframe: Until progressive disease (PD) (up to 60 days)

• Time from start of treatment to the time of progression or death, whichever occurs first
• Progressive disease (target lesions): at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
• Progressive disease (non-target lesions): appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.

Outcome measures

Measure	Arm A: (Start Levocetirizine After Bevacizumab/Capecitabine) n=18 Participants Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle. Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle. Levocetirizine PO 5 mg daily before bed starting on Day 8 of Cycle 1. 5 mg daily before bed Days 1-4 of each cycle starting with cycle 2.	Arm B: (Start Levocetirizine Before Bevacizumab/Capecitabine) Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle. Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle. Levocetirizine PO 5 mg daily starting 7 days prior to initiation of bevacizumab and capecitabine therapy. 5 mg daily Days 1-14 starting with cycle 2.
Progression Free Survival (Arm B) PFS Days = 29	0.946 proportion of patients with PFS Interval 0.848 to 1.0	—
Progression Free Survival (Arm B) PFS Days = 33	0.892 proportion of patients with PFS Interval 0.761 to 1.0	—
Progression Free Survival (Arm B) PFS Days = 44	0.838 proportion of patients with PFS Interval 0.686 to 1.0	—
Progression Free Survival (Arm B) PFS Days = 50	0.686 proportion of patients with PFS Interval 0.507 to 0.928	—
Progression Free Survival (Arm B) PFS Days = 54	0.631 proportion of patients with PFS Interval 0.448 to 0.89	—
Progression Free Survival (Arm B) PFS Days = 60	0.576 proportion of patients with PFS Interval 0.391 to 0.849	—

SECONDARY outcome

Timeframe: Up to 6 months

Population: Arm A: 4 patients not evaluable for outcome measure (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable because of noncompliance after enrollment but before treatment

NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Outcome measures

Measure	Arm A: (Start Levocetirizine After Bevacizumab/Capecitabine) n=19 Participants Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle. Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle. Levocetirizine PO 5 mg daily before bed starting on Day 8 of Cycle 1. 5 mg daily before bed Days 1-4 of each cycle starting with cycle 2.	Arm B: (Start Levocetirizine Before Bevacizumab/Capecitabine) n=23 Participants Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle. Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle. Levocetirizine PO 5 mg daily starting 7 days prior to initiation of bevacizumab and capecitabine therapy. 5 mg daily Days 1-14 starting with cycle 2.
Incidence and Severity of Adverse Events as Measured by Number of Participants Who Experience Grade 3 and Higher Adverse Events Small intestinal obstruction	1 participants	0 participants
Incidence and Severity of Adverse Events as Measured by Number of Participants Who Experience Grade 3 and Higher Adverse Events Fatigue	1 participants	1 participants
Incidence and Severity of Adverse Events as Measured by Number of Participants Who Experience Grade 3 and Higher Adverse Events Urinary tract infection	1 participants	0 participants
Incidence and Severity of Adverse Events as Measured by Number of Participants Who Experience Grade 3 and Higher Adverse Events Blood bilirubin increased	2 participants	0 participants
Incidence and Severity of Adverse Events as Measured by Number of Participants Who Experience Grade 3 and Higher Adverse Events Peripheral motor neuropathy	1 participants	0 participants
Incidence and Severity of Adverse Events as Measured by Number of Participants Who Experience Grade 3 and Higher Adverse Events Peripheral sensory neuropathy	1 participants	0 participants
Incidence and Severity of Adverse Events as Measured by Number of Participants Who Experience Grade 3 and Higher Adverse Events Dyspnea	1 participants	2 participants
Incidence and Severity of Adverse Events as Measured by Number of Participants Who Experience Grade 3 and Higher Adverse Events Hypertension	1 participants	2 participants
Incidence and Severity of Adverse Events as Measured by Number of Participants Who Experience Grade 3 and Higher Adverse Events Thromboembolic event	1 participants	0 participants
Incidence and Severity of Adverse Events as Measured by Number of Participants Who Experience Grade 3 and Higher Adverse Events Anemia	0 participants	1 participants
Incidence and Severity of Adverse Events as Measured by Number of Participants Who Experience Grade 3 and Higher Adverse Events Heart failure	0 participants	1 participants
Incidence and Severity of Adverse Events as Measured by Number of Participants Who Experience Grade 3 and Higher Adverse Events Colonic fistula	0 participants	1 participants
Incidence and Severity of Adverse Events as Measured by Number of Participants Who Experience Grade 3 and Higher Adverse Events Colonic perforation	0 participants	1 participants
Incidence and Severity of Adverse Events as Measured by Number of Participants Who Experience Grade 3 and Higher Adverse Events Gram-negative bacilli infection	0 participants	1 participants
Incidence and Severity of Adverse Events as Measured by Number of Participants Who Experience Grade 3 and Higher Adverse Events Clostridium bloodstream infection	0 participants	1 participants
Incidence and Severity of Adverse Events as Measured by Number of Participants Who Experience Grade 3 and Higher Adverse Events Alanine aminotransferase increased	0 participants	1 participants
Incidence and Severity of Adverse Events as Measured by Number of Participants Who Experience Grade 3 and Higher Adverse Events Anorexia	0 participants	1 participants
Incidence and Severity of Adverse Events as Measured by Number of Participants Who Experience Grade 3 and Higher Adverse Events Bone pain	0 participants	1 participants
Incidence and Severity of Adverse Events as Measured by Number of Participants Who Experience Grade 3 and Higher Adverse Events Generalized muscle weakness	0 participants	1 participants
Incidence and Severity of Adverse Events as Measured by Number of Participants Who Experience Grade 3 and Higher Adverse Events Muscle weakness lower limbs	0 participants	1 participants
Incidence and Severity of Adverse Events as Measured by Number of Participants Who Experience Grade 3 and Higher Adverse Events Urinary retention	0 participants	1 participants
Incidence and Severity of Adverse Events as Measured by Number of Participants Who Experience Grade 3 and Higher Adverse Events Respiratory failure	0 participants	1 participants

Adverse Events

Arm A: (Start Levocetirizine After Bevacizumab/Capecitabine)

Serious events: 5 serious events

Other events: 19 other events

Deaths: 0 deaths

Arm B: (Start Levocetirizine Before Bevacizumab/Capecitabine)

Serious events: 6 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arm A: (Start Levocetirizine After Bevacizumab/Capecitabine) n=19 participants at risk Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle. Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle. Levocetirizine PO 5 mg daily before bed starting on Day 8 of Cycle 1. 5 mg daily before bed Days 1-4 of each cycle starting with cycle 2.	Arm B: (Start Levocetirizine Before Bevacizumab/Capecitabine) n=23 participants at risk Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle. Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle. Levocetirizine PO 5 mg daily starting 7 days prior to initiation of bevacizumab and capecitabine therapy. 5 mg daily Days 1-14 starting with cycle 2.
Blood and lymphatic system disorders Anemia	5.3% 1/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	0.00% 0/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Cardiac disorders Cardiac failure	0.00% 0/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	4.3% 1/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Gastrointestinal disorders Abdominal distension	0.00% 0/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	4.3% 1/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Gastrointestinal disorders Abdominal pain	5.3% 1/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	0.00% 0/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Gastrointestinal disorders Colonic fistula	0.00% 0/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	4.3% 1/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Gastrointestinal disorders Illeal hemorrhage	5.3% 1/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	0.00% 0/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Gastrointestinal disorders Small bowel obstruction	5.3% 1/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	0.00% 0/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
General disorders Death due to disease progression	10.5% 2/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	8.7% 2/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
General disorders Generalized weakness	0.00% 0/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	4.3% 1/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Infections and infestations Urinary tract infection	5.3% 1/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	0.00% 0/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	4.3% 1/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Renal and urinary disorders Acute renal failure	0.00% 0/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	4.3% 1/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Renal and urinary disorders Urinary retention	0.00% 0/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	4.3% 1/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	4.3% 1/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	4.3% 1/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	5.3% 1/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	0.00% 0/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	4.3% 1/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Vascular disorders Hypotension	0.00% 0/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	4.3% 1/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment

Other adverse events

Measure	Arm A: (Start Levocetirizine After Bevacizumab/Capecitabine) n=19 participants at risk Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle. Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle. Levocetirizine PO 5 mg daily before bed starting on Day 8 of Cycle 1. 5 mg daily before bed Days 1-4 of each cycle starting with cycle 2.	Arm B: (Start Levocetirizine Before Bevacizumab/Capecitabine) n=23 participants at risk Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle. Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle. Levocetirizine PO 5 mg daily starting 7 days prior to initiation of bevacizumab and capecitabine therapy. 5 mg daily Days 1-14 starting with cycle 2.
Investigations Hypoalbuminemia	0.00% 0/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	4.3% 1/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Investigations Platelet count decreased	10.5% 2/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	4.3% 1/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Blood and lymphatic system disorders Anemia	0.00% 0/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	4.3% 1/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Cardiac disorders Supraventricular tachycardia	0.00% 0/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	4.3% 1/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Ear and labyrinth disorders Ear pain	5.3% 1/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	0.00% 0/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Ear and labyrinth disorders Hearing impaired	5.3% 1/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	4.3% 1/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Ear and labyrinth disorders Tinnitus	0.00% 0/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	4.3% 1/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Eye disorders Watering eyes	0.00% 0/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	4.3% 1/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Gastrointestinal disorders Abdominal cramps	0.00% 0/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	4.3% 1/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Gastrointestinal disorders Abdominal distension	0.00% 0/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	4.3% 1/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Gastrointestinal disorders Abdominal pain	15.8% 3/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	13.0% 3/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Gastrointestinal disorders Bleeding at stroma site	0.00% 0/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	4.3% 1/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Gastrointestinal disorders Bloating	0.00% 0/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	4.3% 1/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Gastrointestinal disorders Colitis	5.3% 1/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	0.00% 0/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Gastrointestinal disorders Colonic perforation	0.00% 0/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	4.3% 1/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Gastrointestinal disorders Constipation	15.8% 3/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	34.8% 8/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Gastrointestinal disorders Dehydration	0.00% 0/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	4.3% 1/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Gastrointestinal disorders Diarrhea	47.4% 9/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	39.1% 9/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Gastrointestinal disorders Dry mouth	5.3% 1/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	4.3% 1/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Gastrointestinal disorders Dyspepsia	15.8% 3/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	17.4% 4/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Gastrointestinal disorders Flatulence	0.00% 0/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	4.3% 1/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Gastrointestinal disorders Hemmorrhoids	0.00% 0/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	4.3% 1/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Gastrointestinal disorders Mucositis oral	21.1% 4/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	21.7% 5/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Gastrointestinal disorders Nausea	21.1% 4/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	47.8% 11/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Gastrointestinal disorders Oral hemorrhage	15.8% 3/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	0.00% 0/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Gastrointestinal disorders Oral pain	0.00% 0/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	4.3% 1/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Gastrointestinal disorders Stomach pain	0.00% 0/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	4.3% 1/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Gastrointestinal disorders Toothache	5.3% 1/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	0.00% 0/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Gastrointestinal disorders Vomiting	26.3% 5/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	100.0% 23/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
General disorders Chills	15.8% 3/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	8.7% 2/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
General disorders Edema - limbs	15.8% 3/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	13.0% 3/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
General disorders Fatigue	57.9% 11/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	47.8% 11/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
General disorders Fever	10.5% 2/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	8.7% 2/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
General disorders Flu-like symptoms	5.3% 1/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	0.00% 0/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
General disorders Gait disturbance	5.3% 1/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	0.00% 0/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
General disorders Localized edema	5.3% 1/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	0.00% 0/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
General disorders Non-cardiac chest pain	5.3% 1/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	0.00% 0/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
General disorders Pain	26.3% 5/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	4.3% 1/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
General disorders Sweating	5.3% 1/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	0.00% 0/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Infections and infestations Bronchial infection	5.3% 1/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	0.00% 0/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Infections and infestations Clostridium bloodstream infection	0.00% 0/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	4.3% 1/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Infections and infestations Food poisoning "stomach flu"	5.3% 1/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	0.00% 0/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Gastrointestinal disorders Gastroenteritis	5.3% 1/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	0.00% 0/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Infections and infestations Gram-negative bacilli infection	0.00% 0/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	4.3% 1/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Infections and infestations Lip infection	0.00% 0/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	4.3% 1/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Infections and infestations Otitis externa	5.3% 1/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	0.00% 0/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Infections and infestations Right groin infection	0.00% 0/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	4.3% 1/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Infections and infestations Shingles	5.3% 1/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	0.00% 0/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Infections and infestations Sinusitis	5.3% 1/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	0.00% 0/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Infections and infestations Tooth infection	5.3% 1/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	4.3% 1/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Infections and infestations Upper respiratory infection	15.8% 3/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	8.7% 2/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Infections and infestations Urinary tract infection	0.00% 0/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	4.3% 1/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Injury, poisoning and procedural complications Fall	5.3% 1/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	0.00% 0/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Investigations Alanine aminotransferase increased	0.00% 0/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	4.3% 1/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Investigations Alkaline phosphatase increased	0.00% 0/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	4.3% 1/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Investigations Aspartate aminotransferase increased	5.3% 1/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	8.7% 2/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Investigations Blood bilirubin increased	15.8% 3/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	4.3% 1/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Investigations Weight loss	10.5% 2/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	0.00% 0/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Investigations White blood cell decreased	10.5% 2/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	0.00% 0/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Metabolism and nutrition disorders Anorexia	31.6% 6/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	30.4% 7/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Metabolism and nutrition disorders Hypercalcemia	5.3% 1/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	0.00% 0/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	4.3% 1/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Metabolism and nutrition disorders Hypomagnesemia	5.3% 1/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	0.00% 0/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Musculoskeletal and connective tissue disorders Arthralgia	21.1% 4/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	8.7% 2/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Musculoskeletal and connective tissue disorders Back pain	26.3% 5/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	4.3% 1/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Musculoskeletal and connective tissue disorders Bone pain	5.3% 1/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	0.00% 0/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Musculoskeletal and connective tissue disorders Buttock pain	0.00% 0/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	4.3% 1/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Musculoskeletal and connective tissue disorders Chest wall pain	0.00% 0/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	4.3% 1/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Musculoskeletal and connective tissue disorders Cramping in hands and feet	5.3% 1/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	0.00% 0/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Musculoskeletal and connective tissue disorders Foot pain	5.3% 1/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	0.00% 0/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Musculoskeletal and connective tissue disorders Muscle cramps	0.00% 0/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	4.3% 1/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Musculoskeletal and connective tissue disorders Muscle spasms	10.5% 2/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	0.00% 0/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Musculoskeletal and connective tissue disorders Muscle twitching	0.00% 0/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	4.3% 1/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Musculoskeletal and connective tissue disorders Muscle weakness lower limbs	0.00% 0/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	4.3% 1/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Musculoskeletal and connective tissue disorders Myalgia	15.8% 3/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	4.3% 1/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Musculoskeletal and connective tissue disorders Neck pain	5.3% 1/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	8.7% 2/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	4.3% 1/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Nervous system disorders Dizziness	15.8% 3/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	13.0% 3/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Nervous system disorders Dysgeusia	5.3% 1/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	0.00% 0/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Nervous system disorders Headache	36.8% 7/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	13.0% 3/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Nervous system disorders Neuralgia	0.00% 0/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	4.3% 1/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Nervous system disorders Peripheral motor neuropathy	5.3% 1/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	4.3% 1/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Nervous system disorders Peripheral sensory neuropathy	26.3% 5/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	13.0% 3/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Nervous system disorders Presyncope	0.00% 0/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	4.3% 1/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Psychiatric disorders Anxiety	5.3% 1/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	8.7% 2/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Psychiatric disorders Confusion	0.00% 0/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	4.3% 1/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Psychiatric disorders Depression	0.00% 0/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	4.3% 1/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Psychiatric disorders Insomnia	5.3% 1/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	8.7% 2/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Renal and urinary disorders Urinary incontinence	0.00% 0/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	4.3% 1/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Reproductive system and breast disorders Pelvic pain	5.3% 1/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	0.00% 0/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	5.3% 1/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	13.0% 3/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Respiratory, thoracic and mediastinal disorders Cough	31.6% 6/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	17.4% 4/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Respiratory, thoracic and mediastinal disorders Dry nasal passages	5.3% 1/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	0.00% 0/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Respiratory, thoracic and mediastinal disorders Dyspnea	42.1% 8/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	17.4% 4/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Respiratory, thoracic and mediastinal disorders Epistaxis	10.5% 2/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	13.0% 3/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	4.3% 1/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Respiratory, thoracic and mediastinal disorders Hoarseness	5.3% 1/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	4.3% 1/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Respiratory, thoracic and mediastinal disorders Nasal congestion	5.3% 1/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	13.0% 3/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	4.3% 1/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Respiratory, thoracic and mediastinal disorders Sinus disorder	0.00% 0/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	4.3% 1/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Respiratory, thoracic and mediastinal disorders Sore throat	5.3% 1/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	0.00% 0/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Respiratory, thoracic and mediastinal disorders Trachypneic	0.00% 0/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	4.3% 1/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Skin and subcutaneous tissue disorders Brittle nails	0.00% 0/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	8.7% 2/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Skin and subcutaneous tissue disorders Dry skin	31.6% 6/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	13.0% 3/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Skin and subcutaneous tissue disorders Facial rash	5.3% 1/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	0.00% 0/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Skin and subcutaneous tissue disorders Hyperhidrosis	10.5% 2/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	4.3% 1/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Skin and subcutaneous tissue disorders Night sweats	5.3% 1/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	0.00% 0/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Skin and subcutaneous tissue disorders Palmar-Planter erythrodysethsia	15.8% 3/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	34.8% 8/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Skin and subcutaneous tissue disorders Pruritus	5.3% 1/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	4.3% 1/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Skin and subcutaneous tissue disorders Rash maculo-papular	5.3% 1/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	4.3% 1/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Skin and subcutaneous tissue disorders Skin hyperpigmentation	5.3% 1/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	8.7% 2/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Skin and subcutaneous tissue disorders Skin pain	5.3% 1/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	0.00% 0/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Skin and subcutaneous tissue disorders Sores on head	5.3% 1/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	0.00% 0/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Surgical and medical procedures Cataract surgery	0.00% 0/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	4.3% 1/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Vascular disorders Hot flashes	5.3% 1/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	4.3% 1/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Vascular disorders Hypertension	10.5% 2/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	8.7% 2/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment
Vascular disorders Thromboembolic event	5.3% 1/19 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment	0.00% 0/23 Arm A: 4 patients not evaluable for serious adverse event and adverse event collection (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, \& 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable for serious adverse event and adverse event collection because of noncompliance after enrollment but before treatment

Additional Information

Manik A. Amin, M.D.

Washington University School of Medicine

Phone: 314-362-9115

Email: manikamin@wustl.edu

Results disclosure agreements

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