Trial Outcomes & Findings for Atorvastatin Calcium, Oligofructose-Enriched Inulin, or Sulindac in Preventing Cancer in Patients at Increased Risk of Developing Colorectal Neoplasia (NCT NCT00335504)

Last Updated: 2017-02-15

Results Overview

At the Pre-Intervention Evaluation, rectal ACF will be classified with respect to ACF number, crypt number, crypt size, tissue plane, staining intensity, and (optional) lumen shape for each subject. At the Post- Intervention Evaluation, these same parameters will be recorded and incident vs prevalent rectal ACF status will also be recorded. Compare each non-placebo arms versus the placebo arm to screen the three active study agents for possible phase III testing.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

85 participants

Primary outcome timeframe

6 months

Results posted on

2017-02-15

Participant Flow

142 subjects were pre-registered through 10 Cancer Prevention Network (CPN) member organizations from April 2006 to August 2008.

57 subjects were excluded from the trial before assignment to groups: 13 did not have baseline Magnification chromoendoscopy (MCE), 33 had \< 5 rectal ACF, 8 did not meet eligibility criteria, and 3 were withdrawn.

Participant milestones

Participant milestones
Measure	Arm I (Atorvastatin Calcium) Patients receive 20 mg tablet oral atorvastatin once daily.	Arm II (Sulindac) Patients receive 150 mg tablet oral sulindac twice daily.	Arm III (Oligofructose-enriched Inulin) Patients receive 6gm powder oral oligofructose-enriched inulin (Raftilose Synergy 1) twice daily.	Arm IV (Placebo) Patients receive an oral placebo (maltodextrin powder) twice daily.
Overall Study STARTED	22	21	20	22
Overall Study COMPLETED	22	21	20	22
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Atorvastatin Calcium, Oligofructose-Enriched Inulin, or Sulindac in Preventing Cancer in Patients at Increased Risk of Developing Colorectal Neoplasia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (Atorvastatin Calcium) n=22 Participants Patients receive 20 mg tablet oral atorvastatin once daily.	Arm II (Sulindac) n=21 Participants Patients receive 150 mg tablet oral sulindac twice daily.	Arm III (Oligofructose-enriched Inulin) n=20 Participants Patients receive 6gm powder oral oligofructose-enriched inulin (Raftilose Synergy 1) twice daily.	Arm IV (Placebo) n=22 Participants Patients receive an oral placebo (maltodextrin powder) twice daily.	Total n=85 Participants Total of all reporting groups
Age, Continuous	61 Years n=5 Participants	55 Years n=7 Participants	64 Years n=5 Participants	57 Years n=4 Participants	58 Years n=21 Participants
Gender Female	5 Participants n=5 Participants	9 Participants n=7 Participants	8 Participants n=5 Participants	7 Participants n=4 Participants	29 Participants n=21 Participants
Gender Male	17 Participants n=5 Participants	12 Participants n=7 Participants	12 Participants n=5 Participants	15 Participants n=4 Participants	56 Participants n=21 Participants
Region of Enrollment United States	22 participants n=5 Participants	21 participants n=7 Participants	20 participants n=5 Participants	22 participants n=4 Participants	85 participants n=21 Participants
History of Surgical Resection Yes	7 participants n=5 Participants	6 participants n=7 Participants	6 participants n=5 Participants	6 participants n=4 Participants	25 participants n=21 Participants
History of Surgical Resection No	15 participants n=5 Participants	15 participants n=7 Participants	14 participants n=5 Participants	16 participants n=4 Participants	60 participants n=21 Participants

PRIMARY outcome

Timeframe: 6 months

Population: The population used for the analysis is patients having at least 5 rectal ACF and completing both the pre- and post-intervention MCE assessments and using intention to treat principles.

Outcome measures

Outcome measures
Measure	Arm I (Atorvastatin Calcium) n=20 Participants Patients receive 20 mg tablet oral atorvastatin once daily.	Arm II (Sulindac) n=18 Participants Patients receive 150 mg tablet oral sulindac twice daily.	Arm III (Oligofructose-enriched Inulin) n=20 Participants Patients receive 6gm powder oral oligofructose-enriched inulin (Raftilose Synergy 1) twice daily.	Arm IV (Placebo) n=19 Participants Patients receive an oral placebo (maltodextrin powder) twice daily.
Percent Change in Number of Rectal Aberrant Cryptic Foci (ACF) as Measured by Magnification Chromoendoscopy	8.4 percent change in number of ACF Standard Deviation 49.1	-13.3 percent change in number of ACF Standard Deviation 55.4	-8.8 percent change in number of ACF Standard Deviation 49.2	-8.6 percent change in number of ACF Standard Deviation 48.8

SECONDARY outcome

Timeframe: Up to 6 months

Population: Patients with assay data from baseline and post-intervention biopsy samples of normal-appearing rectal mucosa.

Tissue is examined by immunohistochemistry for Ki67. Measured by biopsy samples obtained from normal-appearing rectal mucosa at baseline and after completion of study treatment. Wilcoxon will be used to assess significant differences between the intervention arms.

Outcome measures

Outcome measures
Measure	Arm I (Atorvastatin Calcium) n=16 Participants Patients receive 20 mg tablet oral atorvastatin once daily.	Arm II (Sulindac) n=17 Participants Patients receive 150 mg tablet oral sulindac twice daily.	Arm III (Oligofructose-enriched Inulin) n=13 Participants Patients receive 6gm powder oral oligofructose-enriched inulin (Raftilose Synergy 1) twice daily.	Arm IV (Placebo) n=15 Participants Patients receive an oral placebo (maltodextrin powder) twice daily.
Effects on Proliferation (Ki67 Expression).	6.5 Percent change Standard Deviation 62.3	12.2 Percent change Standard Deviation 52.8	34.7 Percent change Standard Deviation 70.6	13.6 Percent change Standard Deviation 44.1

SECONDARY outcome

Timeframe: Up to 6 months

Population: Patients with assay data from baseline and post-intervention biopsy samples of normal-appearing rectal mucosa.

Tissue is examined by immunohistochemistry for cleaved caspase-3. Measured by biopsy samples obtained from normal-appearing rectal mucosa at baseline and after completion of study treatment. Wilcoxon will be used to assess significant differences between the intervention arms.

Outcome measures

Outcome measures
Measure	Arm I (Atorvastatin Calcium) n=14 Participants Patients receive 20 mg tablet oral atorvastatin once daily.	Arm II (Sulindac) n=15 Participants Patients receive 150 mg tablet oral sulindac twice daily.	Arm III (Oligofructose-enriched Inulin) n=14 Participants Patients receive 6gm powder oral oligofructose-enriched inulin (Raftilose Synergy 1) twice daily.	Arm IV (Placebo) n=12 Participants Patients receive an oral placebo (maltodextrin powder) twice daily.
Effects on Apoptosis (Caspase-3 Expression).	106.0 Percent change of caspase-3 Standard Deviation 140.3	131.9 Percent change of caspase-3 Standard Deviation 154.1	120.5 Percent change of caspase-3 Standard Deviation 195.6	130.6 Percent change of caspase-3 Standard Deviation 81.8

SECONDARY outcome

Timeframe: Up to 30 days after completion of study treatment

Defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with participation in a study, whether or not related to that participation. Graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 3.0. Number of adverse events per grade level.

Outcome measures

Outcome measures
Measure	Arm I (Atorvastatin Calcium) n=22 Participants Patients receive 20 mg tablet oral atorvastatin once daily.	Arm II (Sulindac) n=21 Participants Patients receive 150 mg tablet oral sulindac twice daily.	Arm III (Oligofructose-enriched Inulin) n=20 Participants Patients receive 6gm powder oral oligofructose-enriched inulin (Raftilose Synergy 1) twice daily.	Arm IV (Placebo) n=22 Participants Patients receive an oral placebo (maltodextrin powder) twice daily.
Adverse Events. Grade 3	2 adverse events	2 adverse events	0 adverse events	1 adverse events
Adverse Events. Grade 1	11 adverse events	12 adverse events	10 adverse events	15 adverse events
Adverse Events. Grade 2	5 adverse events	4 adverse events	4 adverse events	13 adverse events

Adverse Events

Arm I (Atorvastatin Calcium)

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Arm II (Sulindac)

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Arm III (Oligofructose-enriched Inulin)

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Arm IV (Placebo)

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Dr. Paul Limburg

Mayo Clinic

Phone: 507-266-9093

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Arm I (Atorvastatin Calcium) n=22 participants at risk Patients receive 20 mg tablet oral atorvastatin once daily.	Arm II (Sulindac) n=21 participants at risk Patients receive 150 mg tablet oral sulindac twice daily.	Arm III (Oligofructose-enriched Inulin) n=20 participants at risk Patients receive 6gm powder oral oligofructose-enriched inulin (Raftilose Synergy 1) twice daily.	Arm IV (Placebo) n=22 participants at risk Patients receive an oral placebo (maltodextrin powder) twice daily.
General disorders Fatigue	13.6% 3/22 • Number of events 4 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	4.8% 1/21 • Number of events 1 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	0.00% 0/20 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	0.00% 0/22 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3
General disorders Pain	9.1% 2/22 • Number of events 2 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	4.8% 1/21 • Number of events 1 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	5.0% 1/20 • Number of events 1 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	9.1% 2/22 • Number of events 3 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3
Gastrointestinal disorders Abdominal pain	0.00% 0/22 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	9.5% 2/21 • Number of events 2 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	5.0% 1/20 • Number of events 1 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	9.1% 2/22 • Number of events 3 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3
General disorders Fever	4.5% 1/22 • Number of events 1 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	4.8% 1/21 • Number of events 1 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	0.00% 0/20 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	13.6% 3/22 • Number of events 3 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3
Injury, poisoning and procedural complications Bruising	0.00% 0/22 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	9.5% 2/21 • Number of events 2 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	0.00% 0/20 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	0.00% 0/22 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3
Skin and subcutaneous tissue disorders Dermatology/Skin - Other Specify	0.00% 0/22 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	9.5% 2/21 • Number of events 3 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	0.00% 0/20 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	9.1% 2/22 • Number of events 2 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3
Skin and subcutaneous tissue disorders Rash	4.5% 1/22 • Number of events 1 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	9.5% 2/21 • Number of events 3 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	0.00% 0/20 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	4.5% 1/22 • Number of events 1 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3
Endocrine disorders Endocrine - Other Specify	0.00% 0/22 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	0.00% 0/21 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	0.00% 0/20 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	4.5% 1/22 • Number of events 2 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3
Gastrointestinal disorders Diarrhea	0.00% 0/22 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	9.5% 2/21 • Number of events 2 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	0.00% 0/20 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	13.6% 3/22 • Number of events 3 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3
Gastrointestinal disorders Flatulence	4.5% 1/22 • Number of events 1 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	0.00% 0/21 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	20.0% 4/20 • Number of events 6 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	22.7% 5/22 • Number of events 6 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3
Gastrointestinal disorders Gastrointestinal - Other Specify	4.5% 1/22 • Number of events 1 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	4.8% 1/21 • Number of events 1 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	15.0% 3/20 • Number of events 3 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	0.00% 0/22 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3
Gastrointestinal disorders Heartburn	0.00% 0/22 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	19.0% 4/21 • Number of events 5 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	0.00% 0/20 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	13.6% 3/22 • Number of events 6 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3
Gastrointestinal disorders Nausea	0.00% 0/22 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	4.8% 1/21 • Number of events 1 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	0.00% 0/20 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	9.1% 2/22 • Number of events 4 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3
Infections and infestations Infection - Other (Specify	9.1% 2/22 • Number of events 3 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	4.8% 1/21 • Number of events 1 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	0.00% 0/20 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	4.5% 1/22 • Number of events 1 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3
Investigations Aspartate aminotransferase increased	4.5% 1/22 • Number of events 2 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	0.00% 0/21 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	0.00% 0/20 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	0.00% 0/22 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3
Investigations Investigations - Other, specify	4.5% 1/22 • Number of events 3 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	0.00% 0/21 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	0.00% 0/20 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	4.5% 1/22 • Number of events 1 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3
Nervous system disorders Neuropathy: sensory	9.1% 2/22 • Number of events 2 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	0.00% 0/21 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	0.00% 0/20 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	0.00% 0/22 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3
General disorders Constitutional Symptoms - Other Specify	0.00% 0/22 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	0.00% 0/21 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	10.0% 2/20 • Number of events 2 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	0.00% 0/22 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3
Ear and labyrinth disorders Auditory/Ear - Other Specify	4.5% 1/22 • Number of events 2 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	0.00% 0/21 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	0.00% 0/20 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	4.5% 1/22 • Number of events 1 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3
Nervous system disorders Headache	9.1% 2/22 • Number of events 3 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	4.8% 1/21 • Number of events 3 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	10.0% 2/20 • Number of events 2 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	4.5% 1/22 • Number of events 1 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3
Musculoskeletal and connective tissue disorders Joint Pain	4.5% 1/22 • Number of events 1 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	0.00% 0/21 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	5.0% 1/20 • Number of events 1 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	9.1% 2/22 • Number of events 2 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3
Musculoskeletal and connective tissue disorders Muscle Pain	9.1% 2/22 • Number of events 2 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	4.8% 1/21 • Number of events 3 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	5.0% 1/20 • Number of events 1 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	0.00% 0/22 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3
Respiratory, thoracic and mediastinal disorders Cough	4.5% 1/22 • Number of events 1 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	4.8% 1/21 • Number of events 1 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	5.0% 1/20 • Number of events 1 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	18.2% 4/22 • Number of events 4 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/22 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	0.00% 0/21 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	0.00% 0/20 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	9.1% 2/22 • Number of events 2 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other Specify	4.5% 1/22 • Number of events 1 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	19.0% 4/21 • Number of events 5 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	10.0% 2/20 • Number of events 2 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3	13.6% 3/22 • Number of events 3 • Start of treatment to 30 days past the end of treatment. Common Toxicity Criteria for Adverse Events (CTCAE) v3