Trial Outcomes & Findings for BIO 300 Non-Small Cell Lung Cancer Study (NCT NCT02567799)

NCT ID: NCT02567799

Last Updated: 2024-01-25

Results Overview

Adverse events of CTCAE v4.0 grade 3 or higher that were possibly, probably or definitely related to BIO 300 Oral Suspension and have occurred before or during concurrent chemoradiotherapy were considered dose limiting toxicities.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 21 participants
• Primary outcome timeframe: Day 1 up to 6 weeks or maximum tolerated dose
• Results posted on: 2024-01-25

Participant Flow

Participant milestones

Measure	BIO 300 Oral Suspension (500 mg/Day) BIO 300 Oral Suspension (500 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).	BIO 300 Oral Suspension (1000 mg/Day) BIO 300 Oral Suspension (1000 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).	BIO 300 Oral Suspension (1500 mg/Day) BIO 300 Oral Suspension (1500 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).
Concurrent Chemoradiotherapy STARTED	7	7	7
Concurrent Chemoradiotherapy COMPLETED	6	4	6
Concurrent Chemoradiotherapy NOT COMPLETED	1	3	1
Follow-up STARTED	6	4	6
Follow-up COMPLETED	4	3	2
Follow-up NOT COMPLETED	2	1	4

Reasons for withdrawal

Measure	BIO 300 Oral Suspension (500 mg/Day) BIO 300 Oral Suspension (500 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).	BIO 300 Oral Suspension (1000 mg/Day) BIO 300 Oral Suspension (1000 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).	BIO 300 Oral Suspension (1500 mg/Day) BIO 300 Oral Suspension (1500 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).
Concurrent Chemoradiotherapy Death	1	0	0
Concurrent Chemoradiotherapy Adverse Event	0	1	0
Concurrent Chemoradiotherapy Progressive Disease	0	2	1
Follow-up Death	1	0	1
Follow-up Progressive Disease	1	1	3

Baseline Characteristics

BIO 300 Non-Small Cell Lung Cancer Study

Baseline characteristics by cohort

Measure	BIO 300 Oral Suspension (500 mg/Day) n=7 Participants BIO 300 Oral Suspension (500 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).	BIO 300 Oral Suspension (1000 mg/Day) n=7 Participants BIO 300 Oral Suspension (1000 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).	BIO 300 Oral Suspension (1500 mg/Day) n=7 Participants BIO 300 Oral Suspension (1500 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).	Total n=21 Participants Total of all reporting groups
Age, Continuous	78 years n=5 Participants	69 years n=7 Participants	57 years n=5 Participants	69 years n=4 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	5 Participants n=7 Participants	1 Participants n=5 Participants	11 Participants n=4 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants	10 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants	18 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	19 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	7 participants n=5 Participants	7 participants n=7 Participants	7 participants n=5 Participants	21 participants n=4 Participants
Initial Tumor Stage Stage II	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Initial Tumor Stage Stage III	5 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	14 Participants n=4 Participants
Initial Tumor Stage Stage IV	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants
Tumor Histology Squamous	3 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	10 Participants n=4 Participants
Tumor Histology Adenocarcinoma	4 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	11 Participants n=4 Participants
Primary Tumor Location Left Upper Lobe	3 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	7 Participants n=4 Participants
Primary Tumor Location Left Lower Lobe	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants
Primary Tumor Location Right Upper Lobe	3 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	9 Participants n=4 Participants
Primary Tumor Location Right Middle Lobe	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Primary Tumor Location Right Lower Lobe	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants

PRIMARY outcome

Timeframe: Day 1 up to 6 weeks or maximum tolerated dose

Adverse events of CTCAE v4.0 grade 3 or higher that were possibly, probably or definitely related to BIO 300 Oral Suspension and have occurred before or during concurrent chemoradiotherapy were considered dose limiting toxicities.

Outcome measures

Measure	BIO 300 Oral Suspension (500 mg/Day) n=6 Participants BIO 300 Oral Suspension (500 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).	BIO 300 Oral Suspension (1000 mg/Day) n=7 Participants BIO 300 Oral Suspension (1000 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).	BIO 300 Oral Suspension (1500 mg/Day) n=7 Participants BIO 300 Oral Suspension (1500 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).
Number of Participants With BIO 300 Oral Suspension-related Dose Limiting Toxicity Number of Participants Experiencing DLTs	0 Participants	0 Participants	0 Participants
Number of Participants With BIO 300 Oral Suspension-related Dose Limiting Toxicity Number of Participants That Did Not Experience a DLT	6 Participants	7 Participants	7 Participants

SECONDARY outcome

Timeframe: Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants.

Outcome measures

Measure	BIO 300 Oral Suspension (500 mg/Day) n=7 Participants BIO 300 Oral Suspension (500 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).	BIO 300 Oral Suspension (1000 mg/Day) n=7 Participants BIO 300 Oral Suspension (1000 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).	BIO 300 Oral Suspension (1500 mg/Day) n=7 Participants BIO 300 Oral Suspension (1500 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).
Number of Participants With Adverse Events Throughout the Study	7 Participants	7 Participants	7 Participants

SECONDARY outcome

Timeframe: Day 1, prior to 1st dose then 0.5, 1, 2, 3, 4, 8 and 24 hours post dose

Population: Only participants that had blood draws for pharmacokinetics were analyzed

Outcome measures

Measure	BIO 300 Oral Suspension (500 mg/Day) n=6 Participants BIO 300 Oral Suspension (500 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).	BIO 300 Oral Suspension (1000 mg/Day) n=6 Participants BIO 300 Oral Suspension (1000 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).	BIO 300 Oral Suspension (1500 mg/Day) n=7 Participants BIO 300 Oral Suspension (1500 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).
Mean Maximum Serum Concentration (Cmax) of BIO 300 Administered in the Absence of Chemotherapy	174 ng/mL Standard Deviation 74	302 ng/mL Standard Deviation 194	388 ng/mL Standard Deviation 264

SECONDARY outcome

Timeframe: Day 1, prior to 1st dose then 0.5, 1, 2, 3, 4, 8 and 24 hours post dose

Population: Only participants that had blood draws for pharmacokinetics were analyzed

Outcome measures

Measure	BIO 300 Oral Suspension (500 mg/Day) n=6 Participants BIO 300 Oral Suspension (500 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).	BIO 300 Oral Suspension (1000 mg/Day) n=6 Participants BIO 300 Oral Suspension (1000 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).	BIO 300 Oral Suspension (1500 mg/Day) n=7 Participants BIO 300 Oral Suspension (1500 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).
Mean Area Under the Serum Concentration Curve (AUC) of BIO 300 Administered in the Absence of Chemotherapy	857 ng*hr/mL Standard Deviation 341	1493 ng*hr/mL Standard Deviation 1123	1570 ng*hr/mL Standard Deviation 883

SECONDARY outcome

Timeframe: Week 1 or 2, during the 1st or 2nd chemotherapy infusion, prior to 1st dose then 0.5, 1, 2, 3, 4, 8, and 24 hours post dose

Population: Only participants that had blood draws for pharmacokinetics were analyzed

Outcome measures

Measure	BIO 300 Oral Suspension (500 mg/Day) n=6 Participants BIO 300 Oral Suspension (500 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).	BIO 300 Oral Suspension (1000 mg/Day) n=6 Participants BIO 300 Oral Suspension (1000 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).	BIO 300 Oral Suspension (1500 mg/Day) n=7 Participants BIO 300 Oral Suspension (1500 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).
Mean Maximum Serum Concentration (Cmax) of BIO 300 When Administered in Combination With Paclitaxel and Carboplatin	155 ng/mL Standard Deviation 30	427 ng/mL Standard Deviation 339	414 ng/mL Standard Deviation 257

SECONDARY outcome

Timeframe: Week 1 or 2, during the 1st or 2nd chemotherapy infusion, prior to 1st dose then 0.5, 1, 2, 3, 4, 8, and 24 hours post dose

Population: Only participants that had blood draws for pharmacokinetics were analyzed

Outcome measures

Measure	BIO 300 Oral Suspension (500 mg/Day) n=6 Participants BIO 300 Oral Suspension (500 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).	BIO 300 Oral Suspension (1000 mg/Day) n=6 Participants BIO 300 Oral Suspension (1000 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).	BIO 300 Oral Suspension (1500 mg/Day) n=7 Participants BIO 300 Oral Suspension (1500 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).
Mean Area Under the Serum Concentration Curve (AUC) of BIO 300 When Administered in Combination With Paclitaxel and Carboplatin	1371 ng*hr/mL Standard Deviation 1174	1578 ng*hr/mL Standard Deviation 726	1821 ng*hr/mL Standard Deviation 964

SECONDARY outcome

Timeframe: Week 1 or 2, during the 1st or 2nd chemotherapy infusion, prior to BIO 300 dose then 0.5, 1, 2, 3, 4, 8 and 24 hours post initial dose

Population: Only participants that had blood draws for pharmacokinetics were analyzed

Outcome measures

Measure	BIO 300 Oral Suspension (500 mg/Day) n=6 Participants BIO 300 Oral Suspension (500 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).	BIO 300 Oral Suspension (1000 mg/Day) n=6 Participants BIO 300 Oral Suspension (1000 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).	BIO 300 Oral Suspension (1500 mg/Day) n=3 Participants BIO 300 Oral Suspension (1500 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).
Mean Maximum Serum Concentration (Cmax) of Paclitaxel When Administered in Combination With BIO 300	665.5 ng/mL Standard Deviation 588.06	1026.5 ng/mL Standard Deviation 260.36	307.6 ng/mL Standard Deviation 288.2

SECONDARY outcome

Timeframe: Week 1 or 2, during the 1st or 2nd chemotherapy infusion, prior to BIO 300 dose then 0.5, 1, 2, 3, 4, 8 and 24 hours post initial dose

Population: Only participants that had blood draws for pharmacokinetics were analyzed

Outcome measures

Measure	BIO 300 Oral Suspension (500 mg/Day) n=6 Participants BIO 300 Oral Suspension (500 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).	BIO 300 Oral Suspension (1000 mg/Day) n=6 Participants BIO 300 Oral Suspension (1000 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).	BIO 300 Oral Suspension (1500 mg/Day) n=3 Participants BIO 300 Oral Suspension (1500 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).
Mean Area Under the Serum Concentration Curve (AUC) of Paclitaxel When Administered in Combination With BIO 300	1236.51 ng*hr/mL Standard Deviation 680.63	1796.1 ng*hr/mL Standard Deviation 409.49	755.27 ng*hr/mL Standard Deviation 306.45

SECONDARY outcome

Timeframe: Week 1 or 2, during the 1st or 2nd chemotherapy infusion, prior to BIO 300 dose then 0.5, 1, 2, 3, 4, 8 and 24 hours post initial dose

Population: Only participants that had blood draws for pharmacokinetics were analyzed

Outcome measures

Measure	BIO 300 Oral Suspension (500 mg/Day) n=6 Participants BIO 300 Oral Suspension (500 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).	BIO 300 Oral Suspension (1000 mg/Day) n=6 Participants BIO 300 Oral Suspension (1000 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).	BIO 300 Oral Suspension (1500 mg/Day) n=3 Participants BIO 300 Oral Suspension (1500 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).
Mean Maximum Serum Concentration (Cmax) of Carboplatin When Administered in Combination With BIO 300	7594 ng/mL Standard Deviation 1946.03	9938.33 ng/mL Standard Deviation 3452.58	12883.33 ng/mL Standard Deviation 7446.87

SECONDARY outcome

Timeframe: Week1 or 2, during the 1st or 2nd chemotherapy infusion, prior to BIO 300 dose then 0.5, 1, 2, 3, 4, 8 and 24 hours post initial dose

Population: Only participants that had blood draws for pharmacokinetics were analyzed

Outcome measures

Measure	BIO 300 Oral Suspension (500 mg/Day) n=6 Participants BIO 300 Oral Suspension (500 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).	BIO 300 Oral Suspension (1000 mg/Day) n=6 Participants BIO 300 Oral Suspension (1000 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).	BIO 300 Oral Suspension (1500 mg/Day) n=3 Participants BIO 300 Oral Suspension (1500 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).
Mean Area Under the Serum Concentration Curve (AUC) of Carboplatin When Administered in Combination With BIO 300	30810.04 ng*hr/mL Standard Deviation 5729.8	41785.18 ng*hr/mL Standard Deviation 11133.8	41753.3 ng*hr/mL Standard Deviation 14462.78

SECONDARY outcome

Timeframe: Screening, once weekly during weeks 1-6 of concurrent chemoradiotherapy prior to BIO 300, paclitaxel, and carboplatin dose, and once at the end of consolidation, 3 months and 6 months after the completion of RT

Population: Analysis population only includes subjects that had a baseline measurement during the screening visit

Measuring change from baseline (screening visit) of TGF-beta isoform 1 (TGFB1)

Outcome measures

Measure	BIO 300 Oral Suspension (500 mg/Day) n=6 Participants BIO 300 Oral Suspension (500 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).	BIO 300 Oral Suspension (1000 mg/Day) n=6 Participants BIO 300 Oral Suspension (1000 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).	BIO 300 Oral Suspension (1500 mg/Day) n=5 Participants BIO 300 Oral Suspension (1500 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).
Percent Change From Baseline in Expression Levels of Serum TGF-beta Isoform 1 (TGFB1) 3 months post-RT	205.7 Percent change from baseline Standard Deviation 161.2	144.9 Percent change from baseline Standard Deviation 96.4	83.1 Percent change from baseline Standard Deviation 18.7
Percent Change From Baseline in Expression Levels of Serum TGF-beta Isoform 1 (TGFB1) Week 1	141.8 Percent change from baseline Standard Deviation 64.1	96.7 Percent change from baseline Standard Deviation 5.1	117.3 Percent change from baseline Standard Deviation 48.5
Percent Change From Baseline in Expression Levels of Serum TGF-beta Isoform 1 (TGFB1) Week 2	130.3 Percent change from baseline Standard Deviation 79.9	127.5 Percent change from baseline Standard Deviation 77.9	96.7 Percent change from baseline Standard Deviation 38.8
Percent Change From Baseline in Expression Levels of Serum TGF-beta Isoform 1 (TGFB1) Week 3	108.6 Percent change from baseline Standard Deviation 79.0	60.1 Percent change from baseline Standard Deviation 40.1	74.4 Percent change from baseline Standard Deviation 25.9
Percent Change From Baseline in Expression Levels of Serum TGF-beta Isoform 1 (TGFB1) Week 4	90.6 Percent change from baseline Standard Deviation 66.0	69.0 Percent change from baseline Standard Deviation 43.8	55.8 Percent change from baseline Standard Deviation 19.9
Percent Change From Baseline in Expression Levels of Serum TGF-beta Isoform 1 (TGFB1) Week 5	88.5 Percent change from baseline Standard Deviation 86.8	61.7 Percent change from baseline Standard Deviation 44.3	51.2 Percent change from baseline Standard Deviation 12.1
Percent Change From Baseline in Expression Levels of Serum TGF-beta Isoform 1 (TGFB1) Week 6	142.8 Percent change from baseline Standard Deviation 133.9	69.3 Percent change from baseline Standard Deviation 43.9	33.4 Percent change from baseline Standard Deviation 33.5
Percent Change From Baseline in Expression Levels of Serum TGF-beta Isoform 1 (TGFB1) After consolidation therapy	68.7 Percent change from baseline Standard Deviation 44.2	74.3 Percent change from baseline Standard Deviation 78.5	60.8 Percent change from baseline Standard Deviation 28.4
Percent Change From Baseline in Expression Levels of Serum TGF-beta Isoform 1 (TGFB1) 6 months post-RT	106.5 Percent change from baseline Standard Deviation 57.4	130.5 Percent change from baseline Standard Deviation 93.5	61.2 Percent change from baseline Standard Deviation 36.6

SECONDARY outcome

Timeframe: Screening, visits 20, 37, 38, 39, 40, 41 & 42 (through visit 41 for surgical participants)

Best Response Rate reported per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by chest CT imaging: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), At least a 20% increase in the sum of diameters of target lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.

Outcome measures

Measure	BIO 300 Oral Suspension (500 mg/Day) n=6 Participants BIO 300 Oral Suspension (500 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).	BIO 300 Oral Suspension (1000 mg/Day) n=7 Participants BIO 300 Oral Suspension (1000 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).	BIO 300 Oral Suspension (1500 mg/Day) n=7 Participants BIO 300 Oral Suspension (1500 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).
Rate of Progressive Disease Evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST) (1.1) Criteria Complete Response	0 Participants	2 Participants	2 Participants
Rate of Progressive Disease Evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST) (1.1) Criteria Partial Response	5 Participants	2 Participants	2 Participants
Rate of Progressive Disease Evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST) (1.1) Criteria Stable Disease	1 Participants	3 Participants	3 Participants
Rate of Progressive Disease Evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST) (1.1) Criteria Progressive Disease	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Screening, visits 20 and 3, 6, 11 & 13 months post radiation therapy

Population: Number of participants vary based on the number of subjects that completed a CT scan each timepoint

Tumor diameter was measured in centimeters. Mean change in tumor diameter from the baseline measurement at screening is reported.

Outcome measures

Measure	BIO 300 Oral Suspension (500 mg/Day) n=6 Participants BIO 300 Oral Suspension (500 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).	BIO 300 Oral Suspension (1000 mg/Day) n=7 Participants BIO 300 Oral Suspension (1000 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).	BIO 300 Oral Suspension (1500 mg/Day) n=7 Participants BIO 300 Oral Suspension (1500 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).
Change in Tumor Diameter as Measured by Diagnostic Computerized Tomography (CT) Scan Visit 20	-1.30 Mean Change from Baseline (cm) Standard Deviation 1.20	0.04 Mean Change from Baseline (cm) Standard Deviation 3.24	-1.15 Mean Change from Baseline (cm) Standard Deviation 1.63
Change in Tumor Diameter as Measured by Diagnostic Computerized Tomography (CT) Scan 13 Months Post-RT	-2.33 Mean Change from Baseline (cm) Standard Deviation 1.31	-3.13 Mean Change from Baseline (cm) Standard Deviation 1.27	-3.05 Mean Change from Baseline (cm) Standard Deviation 5.02
Change in Tumor Diameter as Measured by Diagnostic Computerized Tomography (CT) Scan 3 Months Post-RT	-2.83 Mean Change from Baseline (cm) Standard Deviation 1.35	-2.29 Mean Change from Baseline (cm) Standard Deviation 0.82	-3.54 Mean Change from Baseline (cm) Standard Deviation 1.86
Change in Tumor Diameter as Measured by Diagnostic Computerized Tomography (CT) Scan 6 Months Post-RT	-2.43 Mean Change from Baseline (cm) Standard Deviation 0.99	-3.23 Mean Change from Baseline (cm) Standard Deviation 1.02	-3.42 Mean Change from Baseline (cm) Standard Deviation 2.08
Change in Tumor Diameter as Measured by Diagnostic Computerized Tomography (CT) Scan 9 Months Post-RT	-2.58 Mean Change from Baseline (cm) Standard Deviation 0.87	-3.25 Mean Change from Baseline (cm) Standard Deviation 0.49	-5.0 Mean Change from Baseline (cm) Standard Deviation 1.75
Change in Tumor Diameter as Measured by Diagnostic Computerized Tomography (CT) Scan 11 Months Post-RT	-2.55 Mean Change from Baseline (cm) Standard Deviation 0.95	-3.10 Mean Change from Baseline (cm) Standard Deviation 0.56	-5.9 Mean Change from Baseline (cm) Standard Deviation 0

SECONDARY outcome

Timeframe: Screening and months 6 & 13 post radiation therapy completion

Population: Number of participants varies based on the number of study subjects that received each assessment

Outcome measures

Measure	BIO 300 Oral Suspension (500 mg/Day) n=7 Participants BIO 300 Oral Suspension (500 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).	BIO 300 Oral Suspension (1000 mg/Day) n=7 Participants BIO 300 Oral Suspension (1000 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).	BIO 300 Oral Suspension (1500 mg/Day) n=7 Participants BIO 300 Oral Suspension (1500 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).
DLCO as Measured by Pulmonary Function Test (PFT) Baseline	12.12 mL/mmHg/Min Standard Deviation 3.80	14.96 mL/mmHg/Min Standard Deviation 3.28	16.15 mL/mmHg/Min Standard Deviation 6.60
DLCO as Measured by Pulmonary Function Test (PFT) 6 months post-RT	10.83 mL/mmHg/Min Standard Deviation 4.31	10.46 mL/mmHg/Min Standard Deviation 4.27	11.28 mL/mmHg/Min Standard Deviation 5.82
DLCO as Measured by Pulmonary Function Test (PFT) 13 months post-RT	11.65 mL/mmHg/Min Standard Deviation 4.61	9.48 mL/mmHg/Min Standard Deviation 1.92	18.95 mL/mmHg/Min Standard Deviation 1.09

SECONDARY outcome

Timeframe: Screening, visits 20 & 37 and 9 & 13 months post radiation therapy for non-surgical participants; screening only for surgical participants

Outcome measures

Measure	BIO 300 Oral Suspension (500 mg/Day) n=7 Participants BIO 300 Oral Suspension (500 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).	BIO 300 Oral Suspension (1000 mg/Day) n=7 Participants BIO 300 Oral Suspension (1000 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).	BIO 300 Oral Suspension (1500 mg/Day) n=7 Participants BIO 300 Oral Suspension (1500 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).
Number of Participants With Pulmonary Fibrosis Assessed by Four-dimensional Computerized Tomography (4D-CT)	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Screening and months 3, 6, & 13 post radiation therapy completion

Population: Number of participants at each time point vary based on the number of study participants that completed the assessment

The Functional Assessment of Cancer Therapy-Lung Scale Trial Outcome Index (FACT-L TOI) questionnaire is a 36-item self-reporting instrument that measures quality of life specific to patients with cancer. Items are rated on a 5 item (point) Likert Scale, from 0 (not at all) to 4 (very much). Total scores range from 0 to 136 and higher scores indicate better quality of life. The FACT-L TOI questionnaire was scored according to FACT-L Scoring Guidelines Version 4.

Outcome measures

Measure	BIO 300 Oral Suspension (500 mg/Day) n=7 Participants BIO 300 Oral Suspension (500 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).	BIO 300 Oral Suspension (1000 mg/Day) n=7 Participants BIO 300 Oral Suspension (1000 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).	BIO 300 Oral Suspension (1500 mg/Day) n=7 Participants BIO 300 Oral Suspension (1500 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).
Quality of Life (QOL) as Measured by Functional Assessment of Cancer Therapy-Lung Scale Trial Outcome Index (FACT-L TOI) Patient Reported Outcome Questionnaire. 13 months post-RT	50.8 FACT-L Total Score Standard Deviation 22.4	61.5 FACT-L Total Score Standard Deviation 18.1	55.0 FACT-L Total Score Standard Deviation 13.8
Quality of Life (QOL) as Measured by Functional Assessment of Cancer Therapy-Lung Scale Trial Outcome Index (FACT-L TOI) Patient Reported Outcome Questionnaire. Screening	66.6 FACT-L Total Score Standard Deviation 10.8	53.8 FACT-L Total Score Standard Deviation 21.5	53.9 FACT-L Total Score Standard Deviation 13.2
Quality of Life (QOL) as Measured by Functional Assessment of Cancer Therapy-Lung Scale Trial Outcome Index (FACT-L TOI) Patient Reported Outcome Questionnaire. 3 months post-RT	54.5 FACT-L Total Score Standard Deviation 16.4	63.0 FACT-L Total Score Standard Deviation 6.7	55.6 FACT-L Total Score Standard Deviation 13.3
Quality of Life (QOL) as Measured by Functional Assessment of Cancer Therapy-Lung Scale Trial Outcome Index (FACT-L TOI) Patient Reported Outcome Questionnaire. 6 months post-RT	55.4 FACT-L Total Score Standard Deviation 15.5	49.7 FACT-L Total Score Standard Deviation 13.5	51.4 FACT-L Total Score Standard Deviation 15.0

SECONDARY outcome

Timeframe: Screening and months 3, 6, & 13 post radiation therapy completion

Population: Number of participants at each time point vary based on the number of study participants that completed the assessment

The UCSD-SOBQ is a 24-item patient self-reported questionnaire where items are scored on a 6-point scale (0, "not at all" to 5, "maximal or unable to-do because of breathlessness"). Total scores range from 0 to 120 and lower scores indicate better quality of life.

Outcome measures

Measure	BIO 300 Oral Suspension (500 mg/Day) n=7 Participants BIO 300 Oral Suspension (500 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).	BIO 300 Oral Suspension (1000 mg/Day) n=7 Participants BIO 300 Oral Suspension (1000 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).	BIO 300 Oral Suspension (1500 mg/Day) n=7 Participants BIO 300 Oral Suspension (1500 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).
Quality of Life (QOL) as Measured by University of California, San Diego-Shortness of Breath Questionnaire (UCSD-SOBQ) Patient Reported Outcome Questionnaire. Screening	19.4 UCSD-SOBQ Total Score Standard Deviation 17.4	29.9 UCSD-SOBQ Total Score Standard Deviation 32.3	13.9 UCSD-SOBQ Total Score Standard Deviation 11.9
Quality of Life (QOL) as Measured by University of California, San Diego-Shortness of Breath Questionnaire (UCSD-SOBQ) Patient Reported Outcome Questionnaire. 3 months post-RT	37.0 UCSD-SOBQ Total Score Standard Deviation 33.5	38.0 UCSD-SOBQ Total Score Standard Deviation 13.9	23.0 UCSD-SOBQ Total Score Standard Deviation 20.8
Quality of Life (QOL) as Measured by University of California, San Diego-Shortness of Breath Questionnaire (UCSD-SOBQ) Patient Reported Outcome Questionnaire. 6 months post-RT	46.8 UCSD-SOBQ Total Score Standard Deviation 31.1	54.7 UCSD-SOBQ Total Score Standard Deviation 26.6	24.8 UCSD-SOBQ Total Score Standard Deviation 20.8
Quality of Life (QOL) as Measured by University of California, San Diego-Shortness of Breath Questionnaire (UCSD-SOBQ) Patient Reported Outcome Questionnaire. 13 months post-RT	64.0 UCSD-SOBQ Total Score Standard Deviation 43.6	39.8 UCSD-SOBQ Total Score Standard Deviation 23.4	23.2 UCSD-SOBQ Total Score Standard Deviation 18.0

SECONDARY outcome

Timeframe: Screening, weeks 1, 2, 3, 4, 5, & 6 and months 3 & 6 post radiation therapy completion

Population: Number of participants at each time point vary based on the number of study participants that completed the assessment

The assessment will provide a score (the swallowing questionnaire) from 0 to 5; 1 no problems swallowing; 2 mild soreness only; 3 some difficulty swallowing solids; 4 cannot swallow solids; and 5 cannot swallow liquids.

Outcome measures

Measure	BIO 300 Oral Suspension (500 mg/Day) n=5 Participants BIO 300 Oral Suspension (500 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).	BIO 300 Oral Suspension (1000 mg/Day) n=7 Participants BIO 300 Oral Suspension (1000 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).	BIO 300 Oral Suspension (1500 mg/Day) n=6 Participants BIO 300 Oral Suspension (1500 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).
Extent of Esophagitis by Patient Reported Swallowing Diary Weeks 1-6 Average	1.2 Swallowing Diary Score Standard Deviation 0.36	1.54 Swallowing Diary Score Standard Deviation 0.41	1.64 Swallowing Diary Score Standard Deviation 0.87
Extent of Esophagitis by Patient Reported Swallowing Diary 3 months post-RT	1.0 Swallowing Diary Score Standard Deviation 0	1.0 Swallowing Diary Score Standard Deviation 0	1.6 Swallowing Diary Score Standard Deviation 0.89
Extent of Esophagitis by Patient Reported Swallowing Diary 6 months post-RT	1.33 Swallowing Diary Score Standard Deviation 0.58	1.0 Swallowing Diary Score Standard Deviation 0	1.6 Swallowing Diary Score Standard Deviation 0.55

SECONDARY outcome

Timeframe: Concurrent chemoradiotherapy weeks 1, 2, 3, 4, 5 and 6

Population: Number of participants analyzed at each time point varies based on the number of subjects available for pharmacokinetic blood draw

Outcome measures

Measure	BIO 300 Oral Suspension (500 mg/Day) n=5 Participants BIO 300 Oral Suspension (500 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).	BIO 300 Oral Suspension (1000 mg/Day) n=6 Participants BIO 300 Oral Suspension (1000 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).	BIO 300 Oral Suspension (1500 mg/Day) n=7 Participants BIO 300 Oral Suspension (1500 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).
Mean Weekly BIO 300 Trough Levels, Serum Concentration of BIO 300 Week 1	44.2 ng/mL Standard Deviation 90.0	—	16.02 ng/mL Standard Deviation 23.7
Mean Weekly BIO 300 Trough Levels, Serum Concentration of BIO 300 Week 2	32.6 ng/mL Standard Deviation 44.2	5.84 ng/mL Standard Deviation 8.8	9.96 ng/mL Standard Deviation 13.9
Mean Weekly BIO 300 Trough Levels, Serum Concentration of BIO 300 Week 3	5.1 ng/mL Standard Deviation 4.5	5.56 ng/mL Standard Deviation 8.0	14.12 ng/mL Standard Deviation 18.6
Mean Weekly BIO 300 Trough Levels, Serum Concentration of BIO 300 Week 4	8.3 ng/mL Standard Deviation 13.9	3.82 ng/mL Standard Deviation 6.0	22.66 ng/mL Standard Deviation 44.7
Mean Weekly BIO 300 Trough Levels, Serum Concentration of BIO 300 Week 5	40.7 ng/mL Standard Deviation 36.2	6.71 ng/mL Standard Deviation 11.9	23.54 ng/mL Standard Deviation 38.0
Mean Weekly BIO 300 Trough Levels, Serum Concentration of BIO 300 Week 6	12.4 ng/mL Standard Deviation 15.7	24.0 ng/mL Standard Deviation 32.5	24.54 ng/mL Standard Deviation 23.8

SECONDARY outcome

Timeframe: Concurrent chemoradiotherapy weeks 1, 2, 3, 4, 5 and 6

Population: Number of participants at each time point varies based on the number of participants with blood sample available for analysis.

Serum trough levels of paclitaxel and carboplatin were measured. Carboplatin trough levels were below the limit of quantification at all timepoints and are therefore reported as NA (Not Available).

Outcome measures

Measure	BIO 300 Oral Suspension (500 mg/Day) n=13 Participants BIO 300 Oral Suspension (500 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).	BIO 300 Oral Suspension (1000 mg/Day) n=13 Participants BIO 300 Oral Suspension (1000 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).	BIO 300 Oral Suspension (1500 mg/Day) BIO 300 Oral Suspension (1500 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).
Weekly Paclitaxel Trough Levels, Plasma Concentration of Paclitaxel and Carboplatin Week 1	1.04 ng/mL Standard Deviation 0.08	NA ng/mL Standard Deviation NA NA (Not Applicable) because measurement was below the limit of quantification.	—
Weekly Paclitaxel Trough Levels, Plasma Concentration of Paclitaxel and Carboplatin Week 2	1.09 ng/mL Standard Deviation 0.19	NA ng/mL Standard Deviation NA NA (Not Applicable) because measurement was below the limit of quantification.	—
Weekly Paclitaxel Trough Levels, Plasma Concentration of Paclitaxel and Carboplatin Week 3	1.53 ng/mL Standard Deviation 0.93	NA ng/mL Standard Deviation NA NA (Not Applicable) because measurement was below the limit of quantification.	—
Weekly Paclitaxel Trough Levels, Plasma Concentration of Paclitaxel and Carboplatin Week 4	1.83 ng/mL Standard Deviation 0.81	NA ng/mL Standard Deviation NA NA (Not Applicable) because measurement was below the limit of quantification.	—
Weekly Paclitaxel Trough Levels, Plasma Concentration of Paclitaxel and Carboplatin Week 5	1.90 ng/mL Standard Deviation 0.96	NA ng/mL Standard Deviation NA NA (Not Applicable) because measurement was below the limit of quantification.	—
Weekly Paclitaxel Trough Levels, Plasma Concentration of Paclitaxel and Carboplatin Week 6	1.92 ng/mL Standard Deviation 1.19	NA ng/mL Standard Deviation NA NA (Not Applicable) because measurement was below the limit of quantification.	—

SECONDARY outcome

Timeframe: Screening and months 6 & 13 post radiation therapy completion

Population: Number of participants varies based on the number of study subjects that received each assessment

Outcome measures

Measure	BIO 300 Oral Suspension (500 mg/Day) n=7 Participants BIO 300 Oral Suspension (500 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).	BIO 300 Oral Suspension (1000 mg/Day) n=7 Participants BIO 300 Oral Suspension (1000 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).	BIO 300 Oral Suspension (1500 mg/Day) n=7 Participants BIO 300 Oral Suspension (1500 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).
FVC as Measured by Pulmonary Function Test (PFT) Baseline	2.46 Liters Standard Deviation 0.46	2.79 Liters Standard Deviation 0.56	3.51 Liters Standard Deviation 0.85
FVC as Measured by Pulmonary Function Test (PFT) 6 months post-RT	2.32 Liters Standard Deviation 0.65	2.1 Liters Standard Deviation 0.60	2.93 Liters Standard Deviation 0.74
FVC as Measured by Pulmonary Function Test (PFT) 13 months post-RT	2.32 Liters Standard Deviation 0.67	2.19 Liters Standard Deviation 0.44	3.28 Liters Standard Deviation 0.27

SECONDARY outcome

Timeframe: Screening and months 6 & 13 post radiation therapy completion

Population: Number of participants varies based on the number of study subjects that received each assessment

Outcome measures

Measure	BIO 300 Oral Suspension (500 mg/Day) n=7 Participants BIO 300 Oral Suspension (500 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).	BIO 300 Oral Suspension (1000 mg/Day) n=7 Participants BIO 300 Oral Suspension (1000 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).	BIO 300 Oral Suspension (1500 mg/Day) n=7 Participants BIO 300 Oral Suspension (1500 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).
FEV1 as Measured by Pulmonary Function Test (PFT) Baseline	1.69 Liters Standard Deviation 0.38	1.91 Liters Standard Deviation 0.59	2.39 Liters Standard Deviation 0.83
FEV1 as Measured by Pulmonary Function Test (PFT) 6 months post-RT	1.71 Liters Standard Deviation 0.53	1.29 Liters Standard Deviation 0.13	2.03 Liters Standard Deviation 0.60
FEV1 as Measured by Pulmonary Function Test (PFT) 13 months post-RT	1.61 Liters Standard Deviation 0.55	1.26 Liters Standard Deviation 0.06	2.39 Liters Standard Deviation 0.27

Adverse Events

BIO 300 Oral Suspension (500 mg/Day)

Serious events: 3 serious events

Other events: 7 other events

Deaths: 2 deaths

BIO 300 Oral Suspension (1000 mg/Day)

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

BIO 300 Oral Suspension (1500 mg/Day)

Serious events: 2 serious events

Other events: 7 other events

Deaths: 1 deaths

Serious adverse events

Measure	BIO 300 Oral Suspension (500 mg/Day) n=7 participants at risk BIO 300 Oral Suspension (500 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).	BIO 300 Oral Suspension (1000 mg/Day) n=7 participants at risk BIO 300 Oral Suspension (1000 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).	BIO 300 Oral Suspension (1500 mg/Day) n=7 participants at risk BIO 300 Oral Suspension (1500 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).
Cardiac disorders Atrial Fibrillation	0.00% 0/7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	0.00% 0/7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	14.3% 1/7 • Number of events 1 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.
Cardiac disorders Cardiac Arrest	14.3% 1/7 • Number of events 1 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	0.00% 0/7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	0.00% 0/7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.
Cardiac disorders Sinus Tachycardia	0.00% 0/7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	14.3% 1/7 • Number of events 1 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	0.00% 0/7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.
Gastrointestinal disorders Diarrhea	14.3% 1/7 • Number of events 1 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	0.00% 0/7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	0.00% 0/7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.
General disorders Fever	0.00% 0/7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	0.00% 0/7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	14.3% 1/7 • Number of events 1 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.
Respiratory, thoracic and mediastinal disorders Dyspnea	14.3% 1/7 • Number of events 1 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	0.00% 0/7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	28.6% 2/7 • Number of events 2 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	0.00% 0/7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	14.3% 1/7 • Number of events 1 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.
Vascular disorders Thromboembolic Event	14.3% 1/7 • Number of events 1 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	0.00% 0/7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	14.3% 1/7 • Number of events 1 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.
Gastrointestinal disorders Esophagitis	0.00% 0/7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	0.00% 0/7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	14.3% 1/7 • Number of events 1 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.
Metabolism and nutrition disorders Dehydration	0.00% 0/7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	0.00% 0/7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	14.3% 1/7 • Number of events 1 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.
General disorders Fatigue	14.3% 1/7 • Number of events 1 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	0.00% 0/7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	14.3% 1/7 • Number of events 1 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.
Nervous system disorders Dizziness	14.3% 1/7 • Number of events 1 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	0.00% 0/7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	0.00% 0/7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.
Metabolism and nutrition disorders Hypokalemia	14.3% 1/7 • Number of events 1 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	0.00% 0/7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	0.00% 0/7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.
Metabolism and nutrition disorders Hypomagnesemia	14.3% 1/7 • Number of events 1 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	0.00% 0/7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	0.00% 0/7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.
Vascular disorders Thrombosis	14.3% 1/7 • Number of events 1 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	0.00% 0/7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	0.00% 0/7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.
Infections and infestations Lower Respiratory Tract Infection/Pneumonia	14.3% 1/7 • Number of events 1 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	0.00% 0/7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	0.00% 0/7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.
Respiratory, thoracic and mediastinal disorders Epistaxis	14.3% 1/7 • Number of events 1 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	0.00% 0/7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	0.00% 0/7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.
Respiratory, thoracic and mediastinal disorders Pneumonitis	14.3% 1/7 • Number of events 1 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	0.00% 0/7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	0.00% 0/7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.

Other adverse events

Measure	BIO 300 Oral Suspension (500 mg/Day) n=7 participants at risk BIO 300 Oral Suspension (500 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).	BIO 300 Oral Suspension (1000 mg/Day) n=7 participants at risk BIO 300 Oral Suspension (1000 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).	BIO 300 Oral Suspension (1500 mg/Day) n=7 participants at risk BIO 300 Oral Suspension (1500 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).
Gastrointestinal disorders Dyspepsia	28.6% 2/7 • Number of events 2 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	14.3% 1/7 • Number of events 1 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	28.6% 2/7 • Number of events 2 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.
Gastrointestinal disorders Dysphagia	28.6% 2/7 • Number of events 2 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	28.6% 2/7 • Number of events 2 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	42.9% 3/7 • Number of events 3 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.
Gastrointestinal disorders Diarrhea	28.6% 2/7 • Number of events 2 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	28.6% 2/7 • Number of events 2 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	0.00% 0/7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.
General disorders Edema Limbs	28.6% 2/7 • Number of events 3 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	0.00% 0/7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	0.00% 0/7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.
General disorders Fatigue	28.6% 2/7 • Number of events 2 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	42.9% 3/7 • Number of events 3 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	57.1% 4/7 • Number of events 4 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.
Investigations Neutrophil Count Decreased	42.9% 3/7 • Number of events 3 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	71.4% 5/7 • Number of events 5 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	14.3% 1/7 • Number of events 1 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.
Investigations Platelet Count Decreased	28.6% 2/7 • Number of events 2 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	71.4% 5/7 • Number of events 5 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	28.6% 2/7 • Number of events 2 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.
Metabolism and nutrition disorders Anorexia	28.6% 2/7 • Number of events 2 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	0.00% 0/7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	14.3% 1/7 • Number of events 1 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.
Gastrointestinal disorders Esophagitis	0.00% 0/7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	71.4% 5/7 • Number of events 5 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	100.0% 7/7 • Number of events 7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.
Gastrointestinal disorders Flatulence	14.3% 1/7 • Number of events 1 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	14.3% 1/7 • Number of events 1 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	0.00% 0/7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.
Gastrointestinal disorders Nausea	0.00% 0/7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	42.9% 3/7 • Number of events 3 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	42.9% 3/7 • Number of events 3 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.
Gastrointestinal disorders Vomiting	0.00% 0/7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	28.6% 2/7 • Number of events 2 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	0.00% 0/7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.
General disorders Infusion Related Reaction	0.00% 0/7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	0.00% 0/7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	28.6% 2/7 • Number of events 2 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.
General disorders Pain (Non-Cardiac)	0.00% 0/7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	14.3% 1/7 • Number of events 1 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	14.3% 1/7 • Number of events 1 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.
Investigations Serum Amylase Increased	0.00% 0/7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	14.3% 1/7 • Number of events 1 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	14.3% 1/7 • Number of events 1 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.
Injury, poisoning and procedural complications Radiation Dermatitis	14.3% 1/7 • Number of events 1 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	28.6% 2/7 • Number of events 2 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	57.1% 4/7 • Number of events 4 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.
Investigations Weight Loss	0.00% 0/7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	14.3% 1/7 • Number of events 1 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	42.9% 3/7 • Number of events 3 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.
Investigations White Blood Cell Decreased	14.3% 1/7 • Number of events 1 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	85.7% 6/7 • Number of events 6 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	28.6% 2/7 • Number of events 2 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.
Investigations Anemia	14.3% 1/7 • Number of events 1 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	28.6% 2/7 • Number of events 2 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	28.6% 2/7 • Number of events 2 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.
Investigations Lymphocyte Decreased	0.00% 0/7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	57.1% 4/7 • Number of events 4 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	42.9% 3/7 • Number of events 3 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.
Gastrointestinal disorders Constipation	28.6% 2/7 • Number of events 2 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	42.9% 3/7 • Number of events 3 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	14.3% 1/7 • Number of events 1 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	28.6% 2/7 • Number of events 2 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	28.6% 2/7 • Number of events 2 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.
Metabolism and nutrition disorders Hypoalbuminemia	0.00% 0/7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	14.3% 1/7 • Number of events 1 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	14.3% 1/7 • Number of events 1 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	0.00% 0/7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	28.6% 2/7 • Number of events 2 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.
Metabolism and nutrition disorders Hypomagnesemi	14.3% 1/7 • Number of events 1 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	14.3% 1/7 • Number of events 1 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	14.3% 1/7 • Number of events 1 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.
Metabolism and nutrition disorders Hyponatremia	14.3% 1/7 • Number of events 1 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	14.3% 1/7 • Number of events 1 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	14.3% 1/7 • Number of events 1 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	0.00% 0/7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	28.6% 2/7 • Number of events 2 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.
Musculoskeletal and connective tissue disorders Back Pain	14.3% 1/7 • Number of events 1 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	0.00% 0/7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	14.3% 1/7 • Number of events 1 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.
Musculoskeletal and connective tissue disorders Bone Pain	0.00% 0/7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	28.6% 2/7 • Number of events 2 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	0.00% 0/7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.
Nervous system disorders Dizziness	14.3% 1/7 • Number of events 1 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	28.6% 2/7 • Number of events 2 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	0.00% 0/7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.
Nervous system disorders Dysgeusia	0.00% 0/7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	28.6% 2/7 • Number of events 2 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	0.00% 0/7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.
Nervous system disorders Tremors	0.00% 0/7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	14.3% 1/7 • Number of events 1 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	14.3% 1/7 • Number of events 1 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.
Psychiatric disorders Insomnia	0.00% 0/7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	28.6% 2/7 • Number of events 2 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	14.3% 1/7 • Number of events 1 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.
Respiratory, thoracic and mediastinal disorders Dyspnea	14.3% 1/7 • Number of events 1 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	28.6% 2/7 • Number of events 2 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	28.6% 2/7 • Number of events 2 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.
Respiratory, thoracic and mediastinal disorders Dry Cough	14.3% 1/7 • Number of events 1 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	28.6% 2/7 • Number of events 2 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	28.6% 2/7 • Number of events 2 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.
Respiratory, thoracic and mediastinal disorders Pneumonitis	14.3% 1/7 • Number of events 1 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	57.1% 4/7 • Number of events 4 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	42.9% 3/7 • Number of events 3 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.
Vascular disorders Flushing	0.00% 0/7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	14.3% 1/7 • Number of events 1 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	14.3% 1/7 • Number of events 1 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.
Vascular disorders Hypotension	14.3% 1/7 • Number of events 1 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	14.3% 1/7 • Number of events 1 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.	0.00% 0/7 • Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.

Additional Information

Michael D. Kaytor

Humanetics Corporation

Phone: 952-400-0406

Email: mkaytor@humaneticscorp.com

Results disclosure agreements

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