Trial Outcomes & Findings for Safety and Tolerability of NOX66 in Combination With Palliative Radiotherapy in Patients With Late-Stage Prostate Cancer (NCT NCT03307629)

Last Updated: 2025-07-29

Results Overview

Safety will be assessed through reported incidence of treatment emergent adverse events (AEs), including SAEs, dose limiting toxicities, AEs leading to withdrawal, events that are greater than CTCAE Version 4.03 Grade 2 in severity. Treatment emergent AEs are those with an onset on or after the initiation of therapy. Timepoints for AE /SAE assessment are Day 2 (start of radiation therapy treatment and one day after start of NOX66 treatment), Day 6, End of treatment (Day 16), Week 6, Week 12, and Week 24.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

25 participants

Primary outcome timeframe

Day 2, Day 6, EOT (Day 16), Week 6, Week 12, and Week 24

Results posted on

2025-07-29

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort 1 - NOX66 400mg Daily NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 400mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 2 - NOX66 800mg Daily NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 800mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 3 - NOX66 1200mg Daily NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 1200mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 4 - NOX66 1200mg Daily NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 400mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts.
Overall Study STARTED	4	6	4	11
Overall Study COMPLETED	4	3	4	5
Overall Study NOT COMPLETED	0	3	0	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 2 - NOX66 800mg Daily NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 800mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 4 - NOX66 1200mg Daily NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 400mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts.
Overall Study Withdrawal by Subject	0	2
Overall Study Disease Progression	0	3
Overall Study Death	3	1

Baseline Characteristics

Safety and Tolerability of NOX66 in Combination With Palliative Radiotherapy in Patients With Late-Stage Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1 - NOX66 400mg Daily n=4 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 400mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 2 - NOX66 800mg Daily n=6 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 800mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 3 - NOX66 1200mg Daily n=4 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 1200mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 4 - NOX66 1200mg Daily n=11 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 1200mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Total n=25 Participants Total of all reporting groups
Age, Continuous	72.8 years STANDARD_DEVIATION 8.06 • n=5 Participants	68.5 years STANDARD_DEVIATION 3.73 • n=7 Participants	68.6 years STANDARD_DEVIATION 5.25 • n=5 Participants	70.6 years STANDARD_DEVIATION 6.79 • n=4 Participants	70.1 years STANDARD_DEVIATION 6.01 • n=21 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	11 Participants n=4 Participants	25 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	11 Participants n=4 Participants	25 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment New Zealand	0 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants
Region of Enrollment Georgia	3 participants n=5 Participants	4 participants n=7 Participants	3 participants n=5 Participants	11 participants n=4 Participants	0 participants n=21 Participants
Region of Enrollment Australia	1 participants n=5 Participants	2 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants
Diagnostic PSA level	560.00 ng/mL STANDARD_DEVIATION 579.828 • n=5 Participants	222.38 ng/mL STANDARD_DEVIATION 123.755 • n=7 Participants	488.7 ng/mL STANDARD_DEVIATION 0 • n=5 Participants	154.0 ng/mL STANDARD_DEVIATION 101.402 • n=4 Participants	321.92 ng/mL STANDARD_DEVIATION 258.950 • n=21 Participants
ECOG Performance Status at Screening 0 (Fully active)	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants
ECOG Performance Status at Screening 1 (Ambulatory; No strenuous activity)	4 Participants n=5 Participants	6 Participants n=7 Participants	2 Participants n=5 Participants	9 Participants n=4 Participants	21 Participants n=21 Participants
ECOG Performance Status at Screening 2 (Ambulatory; No work activity)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
ECOG Performance Status at Screening 3 (Limited self-care)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
ECOG Performance Status at Screening 4 (No self-care)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
ECOG Performance Status at Screening 5 (Dead)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants

PRIMARY outcome

Timeframe: Day 2, Day 6, EOT (Day 16), Week 6, Week 12, and Week 24

Population: Safety population = all participants who received at least one dose of NOX66

Outcome measures

Outcome measures
Measure	Cohort 1 - NOX66 400mg Daily n=4 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 400mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 2 - NOX66 800mg Daily n=6 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 800mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 3 - NOX66 1200mg Daily n=4 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 1200mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 4 - NOX66 1200mg Daily n=11 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 1200mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.
Number of Participants With Treatment-Emergent Adverse Events Including SAEs [Safety and Tolerability] of NOX66 Combined With Radiation Therapy at Multiple Timepoints Adverse events (AEs)	4 Participants	5 Participants	2 Participants	9 Participants
Number of Participants With Treatment-Emergent Adverse Events Including SAEs [Safety and Tolerability] of NOX66 Combined With Radiation Therapy at Multiple Timepoints Treatment-emergent adverse events (TEAEs)	4 Participants	5 Participants	2 Participants	9 Participants
Number of Participants With Treatment-Emergent Adverse Events Including SAEs [Safety and Tolerability] of NOX66 Combined With Radiation Therapy at Multiple Timepoints AEs that were DLTs	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Including SAEs [Safety and Tolerability] of NOX66 Combined With Radiation Therapy at Multiple Timepoints AEs leading to withdrawal	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Including SAEs [Safety and Tolerability] of NOX66 Combined With Radiation Therapy at Multiple Timepoints AEs that were greater than Grade 2 severity	1 Participants	3 Participants	1 Participants	6 Participants
Number of Participants With Treatment-Emergent Adverse Events Including SAEs [Safety and Tolerability] of NOX66 Combined With Radiation Therapy at Multiple Timepoints Serious adverse events (SAEs)	0 Participants	3 Participants	1 Participants	1 Participants

PRIMARY outcome

Timeframe: From Baseline to End of Treatment (Day 16), Week 6, Week 12, and Week 24.

Population: Safety population = all patients who received at least one dose of NOX66

Mean change from Baseline in absolute value of safety laboratory results (haematology and biochemistry) assessed at End of Treatment (Day 16), Week 6, Week 12, and Week 24.

Outcome measures

Outcome measures
Measure	Cohort 1 - NOX66 400mg Daily n=4 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 400mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 2 - NOX66 800mg Daily n=6 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 800mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 3 - NOX66 1200mg Daily n=4 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 1200mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 4 - NOX66 1200mg Daily n=11 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 1200mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.
Assessment of Laboratory Results Direct Bilirubin, Day 16 (micromol/L)	0.33 micromol/L Standard Deviation 0.583	-0.78 micromol/L Standard Deviation 1.487	-0.08 micromol/L Standard Deviation 0.415	0.16 micromol/L Standard Deviation 0.494
Assessment of Laboratory Results Direct Bilirubin, Week 6 (micromol/L)	0.33 micromol/L Standard Deviation 0.481	-0.68 micromol/L Standard Deviation 0.864	-0.26 micromol/L Standard Deviation 0.497	-0.09 micromol/L Standard Deviation 0.320
Assessment of Laboratory Results Direct Bilirubin, Week 12 (micromol/L)	-0.12 micromol/L Standard Deviation 0.872	-0.46 micromol/L Standard Deviation 0.173	-0.39 micromol/L Standard Deviation 0.521	0.19 micromol/L Standard Deviation 0.929
Assessment of Laboratory Results Direct Bilirubin, Week 24 (micromol/L)	-0.03 micromol/L Standard Deviation 0.227	-0.70 micromol/L Standard Deviation 0.735	-0.26 micromol/L Standard Deviation 0.549	0.05 micromol/L Standard Deviation 0.135
Assessment of Laboratory Results Total Bilirubin, Day 16 (micromol/L)	1.85 micromol/L Standard Deviation 2.229	-0.35 micromol/L Standard Deviation 3.488	-0.63 micromol/L Standard Deviation 2.447	-0.26 micromol/L Standard Deviation 0.831
Assessment of Laboratory Results Total Bilirubin, Week 6 (micromol/L)	2.45 micromol/L Standard Deviation 1.937	0.59 micromol/L Standard Deviation 0.897	-0.48 micromol/L Standard Deviation 1.754	-0.76 micromol/L Standard Deviation 1.120
Assessment of Laboratory Results Total Bilirubin, Week 12 (micromol/L)	-1.12 micromol/L Standard Deviation 3.749	0.90 micromol/L Standard Deviation 1.137	1.46 micromol/L Standard Deviation 2.034	-0.92 micromol/L Standard Deviation 1.915
Assessment of Laboratory Results Total Bilirubin, Week 24 (micromol/L)	-1.35 micromol/L Standard Deviation 2.928	-0.30 micromol/L Standard Deviation 0.567	-1.43 micromol/L Standard Deviation 3.404	-1.28 micromol/L Standard Deviation 2.483
Assessment of Laboratory Results Creatinine, Day 16 (micromol/L)	7.84 micromol/L Standard Deviation 38.883	4.64 micromol/L Standard Deviation 8.619	5.87 micromol/L Standard Deviation 8.122	-2.90 micromol/L Standard Deviation 8.787
Assessment of Laboratory Results Creatinine, Week 6 (micromol/L)	15.77 micromol/L Standard Deviation 45.051	-5.51 micromol/L Standard Deviation 9.603	-2.33 micromol/L Standard Deviation 3.121	12.89 micromol/L Standard Deviation 21.919
Assessment of Laboratory Results Creatinine, Week 12 (micromol/L)	-4.93 micromol/L Standard Deviation 11.097	16.32 micromol/L Standard Deviation 43.026	-10.70 micromol/L Standard Deviation 0.300	-10.63 micromol/L Standard Deviation 20.908
Assessment of Laboratory Results Creatinine, Week 24 (micromol/L)	-5.98 micromol/L Standard Deviation 17.680	-5.36 micromol/L Standard Deviation 9.032	-8.90 micromol/L Standard Deviation 4.845	-13.39 micromol/L Standard Deviation 16.696

PRIMARY outcome

Timeframe: Baseline to End of treatment (Day 16), Week 12, and Week 24.

Population: Safety population = all patients who received at least one dose of NOX66

Mean change from Baseline in ECG intervals (msec) which are assessed at End of treatment (Day 16), Week 12, and Week 24.

Outcome measures

Outcome measures
Measure	Cohort 1 - NOX66 400mg Daily n=4 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 400mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 2 - NOX66 800mg Daily n=6 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 800mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 3 - NOX66 1200mg Daily n=4 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 1200mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 4 - NOX66 1200mg Daily n=11 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 1200mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.
Assessment of ECG Results QTc interval, Week 24	23.3 msec Standard Deviation 29.57	-2.6 msec Standard Deviation 14.34	6.1 msec Standard Deviation 11.55	0.8 msec Standard Deviation 16.61
Assessment of ECG Results QT interval, Day 16	24.1 msec Standard Deviation 55.08	-1.4 msec Standard Deviation 33.29	9 msec Standard Deviation 22.16	16.1 msec Standard Deviation 33.53
Assessment of ECG Results QT interval, Week 12	33.9 msec Standard Deviation 68.59	4.8 msec Standard Deviation 13.62	-7 msec Standard Deviation 23.67	7.6 msec Standard Deviation 36.6
Assessment of ECG Results QT interval, Week 24	9.7 msec Standard Deviation 34.76	4.8 msec Standard Deviation 27.69	5.2 msec Standard Deviation 25.62	9.2 msec Standard Deviation 12.55
Assessment of ECG Results QTc interval, Day 16	19 msec Standard Deviation 48.92	19.7 msec Standard Deviation 32.1	11.1 msec Standard Deviation 8.12	17.9 msec Standard Deviation 40.32
Assessment of ECG Results QTc interval, Week 12	29.5 msec Standard Deviation 30.88	17.0 msec Standard Deviation 24.99	12.7 msec Standard Deviation 6.39	15 msec Standard Deviation 25.5
Assessment of ECG Results RR interval, Day 16	23.4 msec Standard Deviation 50.15	-56.4 msec Standard Deviation 123.08	7.6 msec Standard Deviation 66.68	4.5 msec Standard Deviation 212.55
Assessment of ECG Results RR interval, Week 12	35.1 msec Standard Deviation 201.4	-11.6 msec Standard Deviation 150.02	-55.6 msec Standard Deviation 140.05	-20.1 msec Standard Deviation 181.42
Assessment of ECG Results RR interval, Week 24	-54.4 msec Standard Deviation 82.71	31.8 msec Standard Deviation 59.97	-17.2 msec Standard Deviation 112.8	39.5 msec Standard Deviation 38.78

PRIMARY outcome

Timeframe: From Baseline to End of Treatment (Day 16), Week 6, Week 12, and Week 24.

Population: Safety population = all patients who received at least one dose of NOX66

Mean change from Baseline in absolute value of safety laboratory results (haematology and biochemistry) assessed at End of Treatment (Day 16), Week 6, Week 12, and Week 24.

Outcome measures

Outcome measures
Measure	Cohort 1 - NOX66 400mg Daily n=4 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 400mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 2 - NOX66 800mg Daily n=6 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 800mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 3 - NOX66 1200mg Daily n=4 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 1200mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 4 - NOX66 1200mg Daily n=11 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 1200mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.
Assessment of Laboratory Results Haemoglobin, Day 16 (g/L)	-0.5 (g/L Standard Deviation 5.066	-6.17 (g/L Standard Deviation 9.579	1.5 (g/L Standard Deviation 10.083	-11.27 (g/L Standard Deviation 8.956
Assessment of Laboratory Results Haemoglobin, Week 6 (g/L)	-7.25 (g/L Standard Deviation 13.598	-8.50 (g/L Standard Deviation 17.540	-4.75 (g/L Standard Deviation 10.532	-11.27 (g/L Standard Deviation 8.810
Assessment of Laboratory Results Haemoglobin, Week 12 (g/L)	11.00 (g/L Standard Deviation 14.855	4.75 (g/L Standard Deviation 21.140	-6.00 (g/L Standard Deviation 6.083	-7.45 (g/L Standard Deviation 15.247
Assessment of Laboratory Results Haemoglobin, Week 24 (g/L)	3.50 (g/L Standard Deviation 6.608	-2.00 (g/L Standard Deviation 21.932	-4.25 (g/L Standard Deviation 6.397	-14.60 (g/L Standard Deviation 23.341
Assessment of Laboratory Results Mean Corpuscular Haemoglobin Concentration, Day 16 (g/L)	-16.75 (g/L Standard Deviation 34.267	-2.40 (g/L Standard Deviation 8.989	-4.33 (g/L Standard Deviation 12.662	0.73 (g/L Standard Deviation 3.062
Assessment of Laboratory Results Mean Corpuscular Haemoglobin Concentration, Week 6 (g/L)	16.75 (g/L Standard Deviation 38.922	-4.25 (g/L Standard Deviation 11.325	1.67 (g/L Standard Deviation 2.082	-2.00 (g/L Standard Deviation 9.960
Assessment of Laboratory Results Mean Corpuscular Haemoglobin Concentration, Week 12 (g/L)	-13.00 (g/L Standard Deviation 29.178	-6.00 (g/L Standard Deviation 8.888	-1.33 (g/L Standard Deviation 12.702	-8.09 (g/L Standard Deviation 28.339
Assessment of Laboratory Results Mean Corpuscular Haemoglobin Concentration, Week 24 (g/L)	-5.5 (g/L Standard Deviation 31.754	-2.67 (g/L Standard Deviation 6.506	-2.67 (g/L Standard Deviation 8.622	-0.80 (g/L Standard Deviation 11.756
Assessment of Laboratory Results Albumin, Day 16 (g/L)	0.80 (g/L Standard Deviation 7.532	-1.88 (g/L Standard Deviation 5.518	0.34 (g/L Standard Deviation 4.418	-0.63 (g/L Standard Deviation 4.785
Assessment of Laboratory Results Albumin, Week 6 (g/L)	-1.68 (g/L Standard Deviation 2.538	4.58 (g/L Standard Deviation 8.423	-0.66 (g/L Standard Deviation 7.579	-3.88 (g/L Standard Deviation 7.482
Assessment of Laboratory Results Albumin, Week 12 (g/L)	0.10 (g/L Standard Deviation 2.761	3.77 (g/L Standard Deviation 8.070	-1.01 (g/L Standard Deviation 9.782	-1.84 (g/L Standard Deviation 5.678
Assessment of Laboratory Results Albumin, Week 24 (g/L)	-0.78 (g/L Standard Deviation 3.497	3.77 (g/L Standard Deviation 8.070	-2.60 (g/L Standard Deviation 8.497	0.58 (g/L Standard Deviation 5.053
Assessment of Laboratory Results Total Protein, Day 16 (g/L)	4.52 (g/L Standard Deviation 6.700	0.36 (g/L Standard Deviation 7.813	-0.08 (g/L Standard Deviation 7.023	0.23 (g/L Standard Deviation 5.626
Assessment of Laboratory Results Total Protein, Week 6 (g/L)	4.04 (g/L Standard Deviation 10.150	5.36 (g/L Standard Deviation 7.813	-0.08 (g/L Standard Deviation 7.023	-2.59 (g/L Standard Deviation 9.247
Assessment of Laboratory Results Total Protein, Week 12 (g/L)	3.63 (g/L Standard Deviation 5.397	7.44 (g/L Standard Deviation 12.707	0.27 (g/L Standard Deviation 15.883	-0.68 (g/L Standard Deviation 6.808
Assessment of Laboratory Results Total Protein, Week 24 (g/L)	1.43 (g/L Standard Deviation 4.742	5.15 (g/L Standard Deviation 14.853	-2.68 (g/L Standard Deviation 13.654	0.15 (g/L Standard Deviation 6.919

PRIMARY outcome

Timeframe: From Baseline to End of Treatment (Day 16), Week 6, Week 12, and Week 24.

Population: Safety population = all patients who received at least one dose of NOX66

Mean change from Baseline in absolute value of safety laboratory results (haematology and biochemistry) assessed at End of Treatment (Day 16), Week 6, Week 12, and Week 24.

Outcome measures

Outcome measures
Measure	Cohort 1 - NOX66 400mg Daily n=4 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 400mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 2 - NOX66 800mg Daily n=6 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 800mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 3 - NOX66 1200mg Daily n=4 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 1200mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 4 - NOX66 1200mg Daily n=11 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 1200mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.
Assessment of Laboratory Results Haematocrit, Day 16 (%)	2.13 Percetange Standard Deviation 1.907	-1.62 Percetange Standard Deviation 3.029	0.80 Percetange Standard Deviation 4.249	-3.64 Percetange Standard Deviation 3.281
Assessment of Laboratory Results Haematocrit, Week 6 (%)	0.83 Percetange Standard Deviation 1.489	-2.23 Percetange Standard Deviation 5.229	-1.58 Percetange Standard Deviation 3.040	-3.25 Percetange Standard Deviation 2.924
Assessment of Laboratory Results Haematocrit, Week 12 (%)	6.83 Percetange Standard Deviation 1.489	-2.23 Percetange Standard Deviation 5.229	-1.58 Percetange Standard Deviation 3.040	-3.25 Percetange Standard Deviation 2.924
Assessment of Laboratory Results Haematocrit, Week 24 (%)	3.48 Percetange Standard Deviation 5.067	-0.40 Percetange Standard Deviation 6.391	-1.28 Percetange Standard Deviation 2.313	-4.42 Percetange Standard Deviation 5.966

PRIMARY outcome

Timeframe: From Baseline to End of Treatment (Day 16), Week 6, Week 12, and Week 24.

Population: Safety population = all patients who received at least one dose of NOX66

Mean change from Baseline in absolute value of safety laboratory results (haematology and biochemistry) assessed at End of Treatment (Day 16), Week 6, Week 12, and Week 24.

Outcome measures

Outcome measures
Measure	Cohort 1 - NOX66 400mg Daily n=4 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 400mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 2 - NOX66 800mg Daily n=6 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 800mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 3 - NOX66 1200mg Daily n=4 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 1200mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 4 - NOX66 1200mg Daily n=11 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 1200mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.
Assessment of Laboratory Results Platelets, Day 16 (10^9/L)	-66.50 10^9cells/L Standard Deviation 50.849	-37.00 10^9cells/L Standard Deviation 135.890	-9.00 10^9cells/L Standard Deviation 121.351	-45.45 10^9cells/L Standard Deviation 104.516
Assessment of Laboratory Results Platelets, Week 6 (10^9/L)	-81.50 10^9cells/L Standard Deviation 49.143	-60.50 10^9cells/L Standard Deviation 86.002	83.00 10^9cells/L Standard Deviation 95.781	-17.09 10^9cells/L Standard Deviation 58.066
Assessment of Laboratory Results Platelets, Week 12 (10^9/L)	-60.0 10^9cells/L Standard Deviation 101.278	36.25 10^9cells/L Standard Deviation 182.967	-8.33 10^9cells/L Standard Deviation 129.894	28.36 10^9cells/L Standard Deviation 73.595
Assessment of Laboratory Results Platelets, Week 24 (10^9/L)	86.75 10^9cells/L Standard Deviation 54.872	-74.00 10^9cells/L Standard Deviation 65.818	34.75 10^9cells/L Standard Deviation 141.354	0.20 10^9cells/L Standard Deviation 79.998
Assessment of Laboratory Results White Blood Cells, Day 16 (10^9/L)	-2.99 10^9cells/L Standard Deviation 1.536	1.20 10^9cells/L Standard Deviation 1.694	2.10 10^9cells/L Standard Deviation 2.217	-2.23 10^9cells/L Standard Deviation 2.269
Assessment of Laboratory Results White Blood Cells, Week 6 (10^9/L)	-3.13 10^9cells/L Standard Deviation 0.884	-1.60 10^9cells/L Standard Deviation 1.632	3.42 10^9cells/L Standard Deviation 2.217	-1.55 10^9cells/L Standard Deviation 1.543
Assessment of Laboratory Results White Blood Cells, Week 12 (10^9/L)	-2.93 10^9cells/L Standard Deviation 2.240	0.69 10^9cells/L Standard Deviation 2.565	4.62 10^9cells/L Standard Deviation 3.975	-1.02 10^9cells/L Standard Deviation 2.331
Assessment of Laboratory Results White Blood Cells, Week 24 (10^9/L)	-2.42 10^9cells/L Standard Deviation 1.754	-1.37 10^9cells/L Standard Deviation 1.086	2.63 10^9cells/L Standard Deviation 3.498	-2.23 10^9cells/L Standard Deviation 2.676
Assessment of Laboratory Results Lymphocytes, Day 16 (10^9/L)	-0.57 10^9cells/L Standard Deviation 0.675	-0.41 10^9cells/L Standard Deviation 0.770	0.35 10^9cells/L Standard Deviation 0.710	-0.66 10^9cells/L Standard Deviation 1.113
Assessment of Laboratory Results Lymphocytes, Week 6 (10^9/L)	0.44 10^9cells/L Standard Deviation 0.497	-0.75 10^9cells/L Standard Deviation 0.838	0.46 10^9cells/L Standard Deviation 0.901	-0.39 10^9cells/L Standard Deviation 1.238
Assessment of Laboratory Results Lymphocytes, Week 12 (10^9/L)	-0.38 10^9cells/L Standard Deviation 0.682	-0.29 10^9cells/L Standard Deviation 0.792	0.24 10^9cells/L Standard Deviation 1.279	-0.34 10^9cells/L Standard Deviation 1.175
Assessment of Laboratory Results Lymphocytes, Week 24 (10^9/L)	-0.45 10^9cells/L Standard Deviation 0.768	-1.25 10^9cells/L Standard Deviation 0.670	0.05 10^9cells/L Standard Deviation 0.854	-0.71 10^9cells/L Standard Deviation 1.761
Assessment of Laboratory Results Neutrophils, Day 16 (10^9/L)	-0.02 10^9cells/L Standard Deviation 1.396	1.38 10^9cells/L Standard Deviation 1.926	1.47 10^9cells/L Standard Deviation 1.683	-1.85 10^9cells/L Standard Deviation 1.926
Assessment of Laboratory Results Neutrophils, Week 6 (10^9/L)	-2.27 10^9cells/L Standard Deviation 0.641	-0.77 10^9cells/L Standard Deviation 0.780	2.76 10^9cells/L Standard Deviation 1.050	-1.50 10^9cells/L Standard Deviation 1.906
Assessment of Laboratory Results Neutrophils, Week 12 (10^9/L)	-2.00 10^9cells/L Standard Deviation 1.956	0.83 10^9cells/L Standard Deviation 1.466	4.27 10^9cells/L Standard Deviation 3.309	-1.03 10^9cells/L Standard Deviation 2.245
Assessment of Laboratory Results Neutrophils, Week 24 (10^9/L)	-1.50 10^9cells/L Standard Deviation 0.776	0.11 10^9cells/L Standard Deviation 0.896	2.47 10^9cells/L Standard Deviation 2.607	-2.33 10^9cells/L Standard Deviation 2.571
Assessment of Laboratory Results Monocytes, Day 16 (10^9/L)	-0.39 10^9cells/L Standard Deviation 0.623	0.19 10^9cells/L Standard Deviation 0.130	0.25 10^9cells/L Standard Deviation 0.200	-0.06 10^9cells/L Standard Deviation 0.315
Assessment of Laboratory Results Monocytes, Week 6 (10^9/L)	-0.42 10^9cells/L Standard Deviation 0622	-0.13 10^9cells/L Standard Deviation 0.108	0.15 10^9cells/L Standard Deviation 0.137	-0.05 10^9cells/L Standard Deviation 0.359
Assessment of Laboratory Results Monocytes, Week 12 (10^9/L)	-0.55 10^9cells/L Standard Deviation 0.629	0.02 10^9cells/L Standard Deviation 0.310	0.12 10^9cells/L Standard Deviation 0.827	0.05 10^9cells/L Standard Deviation 0.396
Assessment of Laboratory Results Monocytes, Week 24 (10^9/L)	-0.42 10^9cells/L Standard Deviation 0.565	-0.11 10^9cells/L Standard Deviation 0.210	0.13 10^9cells/L Standard Deviation 0.541	0.29 10^9cells/L Standard Deviation 0.473
Assessment of Laboratory Results Eosinophils, Day 16 (10^9/L)	0.00 10^9cells/L Standard Deviation 0.081	0.02 10^9cells/L Standard Deviation 0122	0.05 10^9cells/L Standard Deviation 0.097	0.05 10^9cells/L Standard Deviation 0.293
Assessment of Laboratory Results Eosinophils, Week 6 (10^9/L)	0.01 10^9cells/L Standard Deviation 0.059	0.06 10^9cells/L Standard Deviation 0.120	0.04 10^9cells/L Standard Deviation 0.162	-0.06 10^9cells/L Standard Deviation 0.176
Assessment of Laboratory Results Eosinophils, Week 12 (10^9/L)	0.00 10^9cells/L Standard Deviation 0.081	0.04 10^9cells/L Standard Deviation 0.333	-0.02 10^9cells/L Standard Deviation 0.076	-0.07 10^9cells/L Standard Deviation 0.090
Assessment of Laboratory Results Eosinophils, Week 24 (10^9/L)	-0.02 10^9cells/L Standard Deviation 0.042	-0.09 10^9cells/L Standard Deviation 0.148	0.00 10^9cells/L Standard Deviation 0.105	-0.06 10^9cells/L Standard Deviation 0.119
Assessment of Laboratory Results Basophils, Day 16 (10^9/L)	-0.01 10^9cells/L Standard Deviation 0.010	-0.01 10^9cells/L Standard Deviation 0.020	0.00 10^9cells/L Standard Deviation 0.006	0.00 10^9cells/L Standard Deviation 0.023
Assessment of Laboratory Results Basophils, Week 6 (10^9/L)	0.30 10^9cells/L Standard Deviation 0.632	-0.01 10^9cells/L Standard Deviation 0.010	0.02 10^9cells/L Standard Deviation 0.029	0.01 10^9cells/L Standard Deviation 0.019
Assessment of Laboratory Results Basophils, Week 12 (10^9/L)	0.00 10^9cells/L Standard Deviation 0.005	0.03 10^9cells/L Standard Deviation 0.066	0.00 10^9cells/L Standard Deviation 0.006	0.00 10^9cells/L Standard Deviation 0.013
Assessment of Laboratory Results Basophils, Week 24 (10^9/L)	-0.01 10^9cells/L Standard Deviation 0.033	-0.02 10^9cells/L Standard Deviation 0.006	0.00 10^9cells/L Standard Deviation 0.000	-0.01 10^9cells/L Standard Deviation 0.020

PRIMARY outcome

Timeframe: From Baseline to End of Treatment (Day 16), Week 6, Week 12, and Week 24.

Population: Safety population = all patients who received at least one dose of NOX66

Mean change from Baseline in absolute value of safety laboratory results (haematology and biochemistry) assessed at End of Treatment (Day 16), Week 6, Week 12, and Week 24.

Outcome measures

Outcome measures
Measure	Cohort 1 - NOX66 400mg Daily n=4 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 400mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 2 - NOX66 800mg Daily n=6 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 800mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 3 - NOX66 1200mg Daily n=4 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 1200mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 4 - NOX66 1200mg Daily n=11 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 1200mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.
Assessment of Laboratory Results Red Blood Cells, Day 16 (10^12/L)	0.05 10^12cells/L Standard Deviation 0.155	-0.09 10^12cells/L Standard Deviation 0.526	0.25 10^12cells/L Standard Deviation 0.454	-0.37 10^12cells/L Standard Deviation 0.445
Assessment of Laboratory Results Red Blood Cells, Week 6 (10^12/L)	-0.11 10^12cells/L Standard Deviation 0.415	-0.34 10^12cells/L Standard Deviation 0.651	-0.18 10^12cells/L Standard Deviation 0.599	-0.32 10^12cells/L Standard Deviation 0.590
Assessment of Laboratory Results Red Blood Cells, Week 12 (10^12/L)	0.55 10^12cells/L Standard Deviation 0.631	0.18 10^12cells/L Standard Deviation 0.7856	-0.31 10^12cells/L Standard Deviation 0.176	0.01 10^12cells/L Standard Deviation 0.997
Assessment of Laboratory Results Red Blood Cells, Week 24 (10^12/L)	0.09 10^12cells/L Standard Deviation 0.567	-0.13 10^12cells/L Standard Deviation 0.766	-0.28 10^12cells/L Standard Deviation 0.350	-0.32 10^12cells/L Standard Deviation 0.887

PRIMARY outcome

Timeframe: From Baseline to End of Treatment (Day 16), Week 6, Week 12, and Week 24.

Population: Safety population = all patients who received at least one dose of NOX66

Mean change from Baseline in absolute value of safety laboratory results (haematology and biochemistry) assessed at End of Treatment (Day 16), Week 6, Week 12, and Week 24.

Outcome measures

Outcome measures
Measure	Cohort 1 - NOX66 400mg Daily n=4 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 400mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 2 - NOX66 800mg Daily n=6 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 800mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 3 - NOX66 1200mg Daily n=4 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 1200mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 4 - NOX66 1200mg Daily n=11 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 1200mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.
Assessment of Laboratory Results ALP, Day 16 (U/L)	57.53 U/L Standard Deviation 83.556	-35.34 U/L Standard Deviation 142460	-11.53 U/L Standard Deviation 13.814	-33.68 U/L Standard Deviation 176.815
Assessment of Laboratory Results ALP, Week 6 (U/L)	228.28 U/L Standard Deviation 230.132	-95.55 U/L Standard Deviation 193.289	3.60 U/L Standard Deviation 31.794	-11.73 U/L Standard Deviation 184.158
Assessment of Laboratory Results ALP, Week 12 (U/L)	261.98 U/L Standard Deviation 220.518	-142.00 U/L Standard Deviation 225.295	-17.00 U/L Standard Deviation 7.791	144.01 U/L Standard Deviation 250.644
Assessment of Laboratory Results ALP, Week 24 (U/L)	271.30 U/L Standard Deviation 172.254	-167.33 U/L Standard Deviation 328.804	-16.10 U/L Standard Deviation 12.928	-26.66 U/L Standard Deviation 27.916
Assessment of Laboratory Results ALT, Day 16 (U/L)	0.56 U/L Standard Deviation 2.380	0.02 U/L Standard Deviation 13.231	0.13 U/L Standard Deviation 2.347	-0.65 U/L Standard Deviation 8.070
Assessment of Laboratory Results ALT, Week 6 (U/L)	0.93 U/L Standard Deviation 3.621	-1.24 U/L Standard Deviation 4.199	-0.28 U/L Standard Deviation 6.779	0.00 U/L Standard Deviation 8.286
Assessment of Laboratory Results ALT, Week 12 (U/L)	0.40 U/L Standard Deviation 2.637	-5.93 U/L Standard Deviation 15.796	-1.80 U/L Standard Deviation 6.948	-4.58 U/L Standard Deviation 11.113
Assessment of Laboratory Results ALT, Week 24 (U/L)	-0.96 U/L Standard Deviation 1.077	0.56 U/L Standard Deviation 4.801	-0.85 U/L Standard Deviation 2.420	-1.11 U/L Standard Deviation 2.961
Assessment of Laboratory Results AST, Day 16 (U/L)	2.14 U/L Standard Deviation 0.869	5.87 U/L Standard Deviation 6.867	0.00 U/L Standard Deviation 0.000	-4.59 U/L Standard Deviation 9.102
Assessment of Laboratory Results AST, Week 6 (U/L)	5.24 U/L Standard Deviation 6.508	0.74 U/L Standard Deviation 2.413	1.08 U/L Standard Deviation 2.045	-4.87 U/L Standard Deviation 6.70
Assessment of Laboratory Results AST, Week 12 (U/L)	2.14 U/L Standard Deviation 1.919	-1.26 U/L Standard Deviation 5.592	4.03 U/L Standard Deviation 1.861	5.03 U/L Standard Deviation 23.916
Assessment of Laboratory Results AST, Week 24 (U/L)	6.64 U/L Standard Deviation 6.137	-3.42 U/L Standard Deviation 8.199	-0.78 U/L Standard Deviation 2.382	-2.08 U/L Standard Deviation 3.281

PRIMARY outcome

Timeframe: From Baseline to End of Treatment (Day 16), Week 6, Week 12, and Week 24.

Population: Safety population = all patients who received at least one dose of NOX66

Mean change from Baseline in absolute value of safety laboratory results (haematology and biochemistry) assessed at End of Treatment (Day 16), Week 6, Week 12, and Week 24.

Outcome measures

Outcome measures
Measure	Cohort 1 - NOX66 400mg Daily n=4 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 400mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 2 - NOX66 800mg Daily n=6 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 800mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 3 - NOX66 1200mg Daily n=4 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 1200mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 4 - NOX66 1200mg Daily n=11 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 1200mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.
Assessment of Laboratory Results Mean Corpuscular Volume, Day 16 (fL)	4.10 fL Standard Deviation 6.968	-1.58 fL Standard Deviation 5.278	-2.55 fL Standard Deviation 6.125	-0.26 fL Standard Deviation 4.713
Assessment of Laboratory Results Mean Corpuscular Volume, Week 6 (fL)	4.60 fL Standard Deviation 7.124	2.40 fL Standard Deviation 3.713	-0.53 fL Standard Deviation 73.486	0.45 fL Standard Deviation 7.486
Assessment of Laboratory Results Mean Corpuscular Volume, Week 12 (fL)	3.50 fL Standard Deviation 3.696	1.10 fL Standard Deviation 3.451	2.53 fL Standard Deviation 4.957	-1.05 fL Standard Deviation 5.025
Assessment of Laboratory Results Mean Corpuscular Volume, Week 24 (fL)	5.05 fL Standard Deviation 6.357	2.03 fL Standard Deviation 1.704	1.30 fL Standard Deviation 4.577	-2.26 fL Standard Deviation 8.719

PRIMARY outcome

Timeframe: From Baseline to End of Treatment (Day 16), Week 6, Week 12, and Week 24.

Population: Safety population = all patients who received at least one dose of NOX66

Mean change from Baseline in absolute value of safety laboratory results (haematology and biochemistry) assessed at End of Treatment (Day 16), Week 6, Week 12, and Week 24.

Outcome measures

Outcome measures
Measure	Cohort 1 - NOX66 400mg Daily n=4 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 400mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 2 - NOX66 800mg Daily n=6 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 800mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 3 - NOX66 1200mg Daily n=4 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 1200mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 4 - NOX66 1200mg Daily n=11 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 1200mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.
Assessment of Laboratory Results Mean Corpuscular Haemoglobin, Day 16 (pg)	0.13 pg Standard Deviation 0.862	-0.97 pg Standard Deviation 1.632	-1.15 pg Standard Deviation 1.353	0.22 pg Standard Deviation 2.586
Assessment of Laboratory Results Mean Corpuscular Haemoglobin, Week 6 (pg)	0.23 pg Standard Deviation 0.862	0.33 pg Standard Deviation 1.109	0.05 pg Standard Deviation 2.603	-0.17 pg Standard Deviation 1.797
Assessment of Laboratory Results Mean Corpuscular Haemoglobin, Week 12 (pg)	0.23 pg Standard Deviation 1.056	0.05 pg Standard Deviation 1.015	0.83 pg Standard Deviation 2.403	-2.05 pg Standard Deviation 4.155
Assessment of Laboratory Results Mean Corpuscular Haemoglobin, Week 24 (pg)	1.35 pg Standard Deviation 1.212	0.40 pg Standard Deviation 0.985	1.33 pg Standard Deviation 3.822	-0.76 pg Standard Deviation 3.062

PRIMARY outcome

Timeframe: From Baseline to End of Treatment (Day 16), Week 6, Week 12, and Week 24.

Population: Safety population = all patients who received at least one dose of NOX66

Mean change from Baseline in absolute value of safety laboratory results (haematology and biochemistry) assessed at End of Treatment (Day 16), Week 6, Week 12, and Week 24.

Outcome measures

Outcome measures
Measure	Cohort 1 - NOX66 400mg Daily n=4 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 400mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 2 - NOX66 800mg Daily n=6 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 800mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 3 - NOX66 1200mg Daily n=4 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 1200mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 4 - NOX66 1200mg Daily n=11 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 1200mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.
Assessment of Laboratory Results Sodium, Day 16 (mmol/L)	-2.10 mmol/L Standard Deviation 3.075	-0.65 mmol/L Standard Deviation 2.620	-0.180 mmol/L Standard Deviation 2.917	-1.52 mmol/L Standard Deviation 3.257
Assessment of Laboratory Results Sodium, Week 6 (mmol/L)	-2.60 mmol/L Standard Deviation 5.411	1.25 mmol/L Standard Deviation 3.573	0.93 mmol/L Standard Deviation 3.645	-2.09 mmol/L Standard Deviation 3.198
Assessment of Laboratory Results Sodium, Week 12 (mmol/L)	-1.83 mmol/L Standard Deviation 4.664	1.83 mmol/L Standard Deviation 1.756	1.07 mmol/L Standard Deviation 2.901	-1.43 mmol/L Standard Deviation 4.052
Assessment of Laboratory Results Sodium, Week 24 (mmol/L)	-2.73 mmol/L Standard Deviation 1.977	2.23 mmol/L Standard Deviation 4.450	1.45 mmol/L Standard Deviation 3.779	0.60 mmol/L Standard Deviation 1.056
Assessment of Laboratory Results Potassium, Day 16 (mmol/L)	-0.38 mmol/L Standard Deviation 0.078	-0.27 mmol/L Standard Deviation 0.222	-0.25 mmol/L Standard Deviation 0.311	0.03 mmol/L Standard Deviation 0.676
Assessment of Laboratory Results Potassium, Week 6 (mmol/L)	-0.39 mmol/L Standard Deviation 0.401	-0.32 mmol/L Standard Deviation 0.495	-0.19 mmol/L Standard Deviation 0.694	-0.14 mmol/L Standard Deviation 0.736
Assessment of Laboratory Results Potassium, Week 12 (mmol/L)	-0.19 mmol/L Standard Deviation 0.388	-0.12 mmol/L Standard Deviation 0.662	0.24 mmol/L Standard Deviation 0.392	-0.09 mmol/L Standard Deviation 0.710
Assessment of Laboratory Results Potassium, Week 24 (mmol/L)	-0.23 mmol/L Standard Deviation 0.301	-0.01 mmol/L Standard Deviation 0.609	0.10 mmol/L Standard Deviation 0.612	0.35 mmol/L Standard Deviation 0.689
Assessment of Laboratory Results Calcium, Day 16 (mmol/L)	-0.05 mmol/L Standard Deviation 0.058	-0.20 mmol/L Standard Deviation 0.201	-0.07 mmol/L Standard Deviation 0.101	-0.08 mmol/L Standard Deviation 0.507
Assessment of Laboratory Results Calcium, Week 6 (mmol/L)	-0.31 mmol/L Standard Deviation 0.403	0.01 mmol/L Standard Deviation 0.340	-0.15 mmol/L Standard Deviation 0.159	-0.06 mmol/L Standard Deviation 0.504
Assessment of Laboratory Results Calcium, Week 12 (mmol/L)	0.03 mmol/L Standard Deviation 0.144	-0.39 mmol/L Standard Deviation 0.460	-0.09 mmol/L Standard Deviation 0.075	-0.19 mmol/L Standard Deviation 0.451
Assessment of Laboratory Results Calcium, Week 24 (mmol/L)	0.36 mmol/L Standard Deviation 0.415	-0.06 mmol/L Standard Deviation 0.191	0.00 mmol/L Standard Deviation 0.084	-0.07 mmol/L Standard Deviation 0.574

SECONDARY outcome

Timeframe: Week 6, Week 12, and Week 24

Population: Efficacy population = all patients who completed radiation therapy with at least seven days of NOX66 treatment

RECIST response in target irradiated and non-irradiated lesions based on radiographic CT/MRI scan. RECIST 1.1 criteria are Complete Response (CR), Partial Response (PR), Stable Disease(SD) and Progressive Disease (PD). Not Applicable (NA) indicates that a participant did not have measurable target lesions at Screening.

Outcome measures

Outcome measures
Measure	Cohort 1 - NOX66 400mg Daily n=4 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 400mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 2 - NOX66 800mg Daily n=6 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 800mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 3 - NOX66 1200mg Daily n=4 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 1200mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 4 - NOX66 1200mg Daily n=11 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 1200mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.
Change of Target Lesions in Participants According to RECIST 1.1 Criteria Week 6 · Complete Response (CR)	0 Participants	0 Participants	0 Participants	0 Participants
Change of Target Lesions in Participants According to RECIST 1.1 Criteria Week 6 · Partial Response (PR)	0 Participants	0 Participants	0 Participants	1 Participants
Change of Target Lesions in Participants According to RECIST 1.1 Criteria Week 6 · Stable Disease (SD)	4 Participants	4 Participants	4 Participants	8 Participants
Change of Target Lesions in Participants According to RECIST 1.1 Criteria Week 6 · Progressive Disease (PD)	0 Participants	0 Participants	0 Participants	0 Participants
Change of Target Lesions in Participants According to RECIST 1.1 Criteria Week 6 · Not Evaluable (NE)	0 Participants	2 Participants	0 Participants	0 Participants
Change of Target Lesions in Participants According to RECIST 1.1 Criteria Week 6 · Not Applicable (NA)	0 Participants	0 Participants	0 Participants	2 Participants
Change of Target Lesions in Participants According to RECIST 1.1 Criteria Week 12 · Complete Response (CR)	0 Participants	0 Participants	0 Participants	0 Participants
Change of Target Lesions in Participants According to RECIST 1.1 Criteria Week 12 · Partial Response (PR)	0 Participants	1 Participants	0 Participants	2 Participants
Change of Target Lesions in Participants According to RECIST 1.1 Criteria Week 12 · Stable Disease (SD)	4 Participants	2 Participants	3 Participants	5 Participants
Change of Target Lesions in Participants According to RECIST 1.1 Criteria Week 12 · Progressive Disease (PD)	0 Participants	1 Participants	0 Participants	0 Participants
Change of Target Lesions in Participants According to RECIST 1.1 Criteria Week 12 · Not Evaluable (NE)	0 Participants	2 Participants	1 Participants	2 Participants
Change of Target Lesions in Participants According to RECIST 1.1 Criteria Week 12 · Not Applicable (NA)	0 Participants	0 Participants	0 Participants	2 Participants
Change of Target Lesions in Participants According to RECIST 1.1 Criteria Week 24 · Complete Response (CR)	0 Participants	0 Participants	0 Participants	0 Participants
Change of Target Lesions in Participants According to RECIST 1.1 Criteria Week 24 · Partial Response (PR)	0 Participants	1 Participants	0 Participants	1 Participants
Change of Target Lesions in Participants According to RECIST 1.1 Criteria Week 24 · Stable Disease (SD)	3 Participants	2 Participants	3 Participants	2 Participants
Change of Target Lesions in Participants According to RECIST 1.1 Criteria Week 24 · Progressive Disease (PD)	0 Participants	0 Participants	0 Participants	0 Participants
Change of Target Lesions in Participants According to RECIST 1.1 Criteria Week 24 · Not Evaluable (NE)	1 Participants	3 Participants	1 Participants	6 Participants
Change of Target Lesions in Participants According to RECIST 1.1 Criteria Week 24 · Not Applicable (NA)	0 Participants	0 Participants	0 Participants	2 Participants

SECONDARY outcome

Timeframe: Week 6, Week 12, and Week 24

Population: Efficacy population = all patients who completed radiation therapy with at least seven days of NOX66 treatment

RECIST 1.1 assessment of response in Non-Target Lesions as Complete Response (CR), Non-CR/Non-PD, or Progressive Disease (PD). Not Applicable (NA) signifies that the participant did not have non-target lesions at Screening.

Outcome measures

Outcome measures
Measure	Cohort 1 - NOX66 400mg Daily n=4 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 400mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 2 - NOX66 800mg Daily n=6 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 800mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 3 - NOX66 1200mg Daily n=4 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 1200mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 4 - NOX66 1200mg Daily n=11 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 1200mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.
Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria Week 6 · Complete Response (CR)	0 Participants	0 Participants	0 Participants	0 Participants
Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria Week 6 · Non-CR/Non-PD	4 Participants	5 Participants	3 Participants	7 Participants
Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria Week 6 · Progressive Disease (PD)	0 Participants	0 Participants	0 Participants	0 Participants
Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria Week 6 · Not Evaluable (NE)	0 Participants	0 Participants	0 Participants	4 Participants
Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria Week 6 · Not Applicable (NA)	0 Participants	1 Participants	1 Participants	0 Participants
Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria Week 12 · Complete Response (CR)	0 Participants	0 Participants	1 Participants	0 Participants
Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria Week 12 · Non-CR/Non-PD	4 Participants	4 Participants	2 Participants	7 Participants
Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria Week 12 · Progressive Disease (PD)	0 Participants	1 Participants	0 Participants	0 Participants
Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria Week 12 · Not Evaluable (NE)	0 Participants	0 Participants	0 Participants	4 Participants
Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria Week 12 · Not Applicable (NA)	0 Participants	1 Participants	1 Participants	0 Participants
Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria Week 24 · Complete Response (CR)	1 Participants	0 Participants	1 Participants	1 Participants
Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria Week 24 · Non-CR/Non-PD	2 Participants	4 Participants	2 Participants	6 Participants
Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria Week 24 · Progressive Disease (PD)	1 Participants	1 Participants	0 Participants	1 Participants
Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria Week 24 · Not Evaluable (NE)	0 Participants	0 Participants	0 Participants	3 Participants
Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria Week 24 · Not Applicable (NA)	0 Participants	1 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: From enrolment up to Week 6, Week 12, and Week 24

Population: Efficacy population = all patients who completed radiation therapy with at least seven days of NOX66 treatment

Overall RECIST 1.1 response based on combined assessment criteria for target, non-target and new lesions as Complete Response (CR), Partial Response (PR), Stable Disease(SD), or Progressive Disease (PD)

Outcome measures

Outcome measures
Measure	Cohort 1 - NOX66 400mg Daily n=4 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 400mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 2 - NOX66 800mg Daily n=6 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 800mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 3 - NOX66 1200mg Daily n=4 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 1200mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 4 - NOX66 1200mg Daily n=11 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 1200mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.
Overall Response According to RECIST 1.1 Criteria Week 6 · Complete Response (CR)	0 Participants	0 Participants	0 Participants	0 Participants
Overall Response According to RECIST 1.1 Criteria Week 6 · Partial Response (PR)	0 Participants	0 Participants	0 Participants	1 Participants
Overall Response According to RECIST 1.1 Criteria Week 6 · Stable Disease (SD)	4 Participants	3 Participants	4 Participants	9 Participants
Overall Response According to RECIST 1.1 Criteria Week 6 · Progressive Disease (PD)	0 Participants	1 Participants	0 Participants	0 Participants
Overall Response According to RECIST 1.1 Criteria Week 6 · Not Evaluable (NE)	0 Participants	2 Participants	0 Participants	1 Participants
Overall Response According to RECIST 1.1 Criteria Week 12 · Complete Response (CR)	0 Participants	0 Participants	0 Participants	0 Participants
Overall Response According to RECIST 1.1 Criteria Week 12 · Partial Response (PR)	0 Participants	1 Participants	0 Participants	2 Participants
Overall Response According to RECIST 1.1 Criteria Week 12 · Stable Disease (SD)	3 Participants	2 Participants	3 Participants	6 Participants
Overall Response According to RECIST 1.1 Criteria Week 12 · Progressive Disease (PD)	1 Participants	1 Participants	0 Participants	0 Participants
Overall Response According to RECIST 1.1 Criteria Week 12 · Not Evaluable (NE)	0 Participants	2 Participants	1 Participants	3 Participants
Overall Response According to RECIST 1.1 Criteria Week 24 · Complete Response (CR)	0 Participants	0 Participants	0 Participants	0 Participants
Overall Response According to RECIST 1.1 Criteria Week 24 · Partial Response (PR)	0 Participants	1 Participants	0 Participants	0 Participants
Overall Response According to RECIST 1.1 Criteria Week 24 · Stable Disease (SD)	2 Participants	2 Participants	3 Participants	2 Participants
Overall Response According to RECIST 1.1 Criteria Week 24 · Progressive Disease (PD)	1 Participants	0 Participants	0 Participants	3 Participants
Overall Response According to RECIST 1.1 Criteria Week 24 · Not Evaluable (NE)	1 Participants	3 Participants	1 Participants	6 Participants

SECONDARY outcome

Timeframe: From enrolment up to Day 16, Week 6, Week 12, and Week 24

Population: Efficacy population = all patients who completed radiation therapy with at least seven days of NOX66 treatment

Percentage change from baseline in overall pain score based on responses to the BPI-SF, which is scored from 0 to 10, with 0 = no pain and 10 = the most severe pain imaginable.

Outcome measures

Outcome measures
Measure	Cohort 1 - NOX66 400mg Daily n=4 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 400mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 2 - NOX66 800mg Daily n=6 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 800mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 3 - NOX66 1200mg Daily n=4 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 1200mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 4 - NOX66 1200mg Daily n=11 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 1200mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.
Change in Overall Pain Score Using the Brief Pain Inventory - Short Form (BPI-SF) Day 16	-52.186 Percentage change from baseline in score Standard Deviation 56.6238	32.737 Percentage change from baseline in score Standard Deviation 103.7459	3.6 Percentage change from baseline in score Standard Deviation 32.30	-37.2 Percentage change from baseline in score Standard Deviation 37.92
Change in Overall Pain Score Using the Brief Pain Inventory - Short Form (BPI-SF) Week 6	-58.954 Percentage change from baseline in score Standard Deviation 40.1178	-47.815 Percentage change from baseline in score Standard Deviation 35.0069	-44.1 Percentage change from baseline in score Standard Deviation 44.36	-41.8 Percentage change from baseline in score Standard Deviation 42.28
Change in Overall Pain Score Using the Brief Pain Inventory - Short Form (BPI-SF) Week 12	-55.830 Percentage change from baseline in score Standard Deviation 52.9611	-29.175 Percentage change from baseline in score Standard Deviation 82.3088	42.8 Percentage change from baseline in score Standard Deviation 44.46	-37.0 Percentage change from baseline in score Standard Deviation 47.51
Change in Overall Pain Score Using the Brief Pain Inventory - Short Form (BPI-SF) Week 24	10.786 Percentage change from baseline in score Standard Deviation 46.4994	-80.992 Percentage change from baseline in score Standard Deviation 32.9233	-38.4 Percentage change from baseline in score Standard Deviation 35.16	-68.6 Percentage change from baseline in score Standard Deviation 49.04

SECONDARY outcome

Timeframe: From enrolment up to Week 6, Week 12, and Week 24

Population: Efficacy population = all patients who completed radiation therapy with at least seven days of NOX66 treatment

Percentage change from baseline in serum PSA levels (ng/mL) at Week 6, Week 12, and Week 24

Outcome measures

Outcome measures
Measure	Cohort 1 - NOX66 400mg Daily n=4 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 400mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 2 - NOX66 800mg Daily n=6 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 800mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 3 - NOX66 1200mg Daily n=4 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 1200mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 4 - NOX66 1200mg Daily n=11 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 1200mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.
Change in Prostate Specific Antigen (PSA) Levels Week 6	17.79 Percentage change from baseline in PSA Standard Deviation 42.116	-46.67 Percentage change from baseline in PSA Standard Deviation 27.358	0.29 Percentage change from baseline in PSA Standard Deviation 41.424	-19.49 Percentage change from baseline in PSA Standard Deviation 52.989
Change in Prostate Specific Antigen (PSA) Levels Week 12	35.75 Percentage change from baseline in PSA Standard Deviation 31.610	-53.26 Percentage change from baseline in PSA Standard Deviation 31.766	14.82 Percentage change from baseline in PSA Standard Deviation 138.637	-310 Percentage change from baseline in PSA Standard Deviation 73.373
Change in Prostate Specific Antigen (PSA) Levels Week 24	333.51 Percentage change from baseline in PSA Standard Deviation 357.538	-14.85 Percentage change from baseline in PSA Standard Deviation 62.764	374.20 Percentage change from baseline in PSA Standard Deviation 518.309	64.86 Percentage change from baseline in PSA Standard Deviation 195.334

SECONDARY outcome

Timeframe: From enrolment up to Week 6, Week 12, and Week 24

Population: Efficacy population = all patients who completed radiation therapy with at least seven days of NOX66 treatment

Assessment of patient via ECOG Performance Status, which has a scale scored from 0 (Fully Active) to 5 (Dead).

Outcome measures

Outcome measures
Measure	Cohort 1 - NOX66 400mg Daily n=4 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 400mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 2 - NOX66 800mg Daily n=6 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 800mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 3 - NOX66 1200mg Daily n=4 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 1200mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 4 - NOX66 1200mg Daily n=11 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 1200mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.
Change of ECOG Performance Status Screening · 0 (Fully active)	0 Participants	0 Participants	2 Participants	2 Participants
Change of ECOG Performance Status Screening · 1 (Ambulatory; No strenuous activity)	4 Participants	6 Participants	2 Participants	9 Participants
Change of ECOG Performance Status Screening · 2 (Ambulatory; No work activity)	0 Participants	0 Participants	0 Participants	0 Participants
Change of ECOG Performance Status Screening · 3 (Limited self-care)	0 Participants	0 Participants	0 Participants	0 Participants
Change of ECOG Performance Status Screening · 4 (No self-care)	0 Participants	0 Participants	0 Participants	0 Participants
Change of ECOG Performance Status Screening · 5 (Dead)	0 Participants	0 Participants	0 Participants	0 Participants
Change of ECOG Performance Status Week 6 · 0 (Fully active)	0 Participants	1 Participants	2 Participants	1 Participants
Change of ECOG Performance Status Week 6 · 1 (Ambulatory; No strenuous activity)	4 Participants	3 Participants	1 Participants	7 Participants
Change of ECOG Performance Status Week 6 · 2 (Ambulatory; No work activity)	0 Participants	0 Participants	1 Participants	3 Participants
Change of ECOG Performance Status Week 6 · 3 (Limited self-care)	0 Participants	0 Participants	0 Participants	0 Participants
Change of ECOG Performance Status Week 6 · 4 (No self-care)	0 Participants	0 Participants	0 Participants	0 Participants
Change of ECOG Performance Status Week 6 · 5 (Dead)	0 Participants	0 Participants	0 Participants	0 Participants
Change of ECOG Performance Status Week 12 · 0 (Fully active)	0 Participants	2 Participants	2 Participants	2 Participants
Change of ECOG Performance Status Week 12 · 1 (Ambulatory; No strenuous activity)	4 Participants	1 Participants	1 Participants	5 Participants
Change of ECOG Performance Status Week 12 · 2 (Ambulatory; No work activity)	0 Participants	1 Participants	0 Participants	2 Participants
Change of ECOG Performance Status Week 12 · 3 (Limited self-care)	0 Participants	0 Participants	0 Participants	1 Participants
Change of ECOG Performance Status Week 12 · 4 (No self-care)	0 Participants	0 Participants	0 Participants	1 Participants
Change of ECOG Performance Status Week 12 · 5 (Dead)	0 Participants	0 Participants	0 Participants	0 Participants
Change of ECOG Performance Status Week 24 · 0 (Fully active)	0 Participants	2 Participants	2 Participants	2 Participants
Change of ECOG Performance Status Week 24 · 1 (Ambulatory; No strenuous activity)	3 Participants	1 Participants	1 Participants	1 Participants
Change of ECOG Performance Status Week 24 · 2 (Ambulatory; No work activity)	1 Participants	0 Participants	0 Participants	1 Participants
Change of ECOG Performance Status Week 24 · 3 (Limited self-care)	0 Participants	0 Participants	1 Participants	1 Participants
Change of ECOG Performance Status Week 24 · 4 (No self-care)	0 Participants	0 Participants	0 Participants	0 Participants
Change of ECOG Performance Status Week 24 · 5 (Dead)	0 Participants	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From enrolment up to Day 2, End of Treatment (Day 16), Week 6, Week 12, and Week 24

Population: Safety population = all patients who received at least one dose of NOX66

Assessment of patient via physical exam comparing Day 2, End of Treatment (Day 16), Week 6, Week 12, and Week 24 to baseline. Physical exam included abdominal, cardiovascular, dermatologic, gastrointestinal, genitourinary, HEENT (head, eyes, ears, nose, throat), lymphatic, musculoskeletal, neurological, other, and pulmonary exams.

Outcome measures

Outcome measures
Measure	Cohort 1 - NOX66 400mg Daily n=4 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 400mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 2 - NOX66 800mg Daily n=6 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 800mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 3 - NOX66 1200mg Daily n=4 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 1200mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 4 - NOX66 1200mg Daily n=11 Participants NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 1200mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Dermatologic Exam, Week 24 · No change	4 Participants	3 Participants	4 Participants	11 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Dermatologic Exam, Week 24 · Worsened	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Gastrointestinal Exam, Day 2 · Improved	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Gastrointestinal Exam, Day 2 · No change	4 Participants	4 Participants	4 Participants	11 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Gastrointestinal Exam, Day 2 · Worsened	0 Participants	1 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Gastrointestinal Exam, Day 16 · Improved	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Gastrointestinal Exam, Day 16 · No change	4 Participants	5 Participants	4 Participants	11 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Gastrointestinal Exam, Day 16 · Worsened	0 Participants	1 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Gastrointestinal Exam, Week 6 · Improved	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Abdominal Exam, Day 2 · Improved	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Abdominal Exam, Day 2 · No change	4 Participants	5 Participants	4 Participants	11 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Abdominal Exam, Day 2 · Worsened	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Abdominal Exam, Day 16 · Improved	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Abdominal Exam, Day 16 · No change	4 Participants	6 Participants	4 Participants	11 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Abdominal Exam, Day 16 · Worsened	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Gastrointestinal Exam, Week 6 · No change	4 Participants	4 Participants	4 Participants	11 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Abdominal Exam, Week 6 · Improved	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Abdominal Exam, Week 6 · No change	4 Participants	4 Participants	4 Participants	11 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Abdominal Exam, Week 6 · Worsened	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Abdominal Exam, Week 12 · Improved	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Abdominal Exam, Week 12 · No change	4 Participants	4 Participants	4 Participants	11 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Abdominal Exam, Week 12 · Worsened	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Abdominal Exam, Week 24 · Improved	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Abdominal Exam, Week 24 · No change	4 Participants	3 Participants	4 Participants	11 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Abdominal Exam, Week 24 · Worsened	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Cardiovascular Exam, Day 2 · Improved	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Cardiovascular Exam, Day 2 · No change	4 Participants	5 Participants	4 Participants	11 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Cardiovascular Exam, Day 2 · Worsened	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Cardiovascular Exam, Day 16 · Improved	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Cardiovascular Exam, Day 16 · No change	4 Participants	6 Participants	4 Participants	11 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Cardiovascular Exam, Day 16 · Worsened	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Cardiovascular Exam, Week 6 · Improved	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Cardiovascular Exam, Week 6 · No change	4 Participants	4 Participants	4 Participants	11 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Cardiovascular Exam, Week 6 · Worsened	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Cardiovascular Exam, Week 12 · Improved	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Cardiovascular Exam, Week 12 · No change	4 Participants	4 Participants	4 Participants	11 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Cardiovascular Exam, Week 12 · Worsened	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Cardiovascular Exam, Week 24 · Improved	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Cardiovascular Exam, Week 24 · No change	4 Participants	3 Participants	4 Participants	11 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Cardiovascular Exam, Week 24 · Worsened	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Dermatologic Exam, Day 2 · Improved	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Dermatologic Exam, Day 2 · No change	4 Participants	5 Participants	4 Participants	11 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Dermatologic Exam, Day 2 · Worsened	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Dermatologic Exam, Day 16 · Improved	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Dermatologic Exam, Day 16 · No change	4 Participants	5 Participants	4 Participants	11 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Dermatologic Exam, Day 16 · Worsened	0 Participants	1 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Dermatologic Exam, Week 6 · Improved	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Dermatologic Exam, Week 6 · No change	4 Participants	4 Participants	4 Participants	11 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Dermatologic Exam, Week 6 · Worsened	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Dermatologic Exam, Week 12 · Improved	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Dermatologic Exam, Week 12 · No change	4 Participants	4 Participants	4 Participants	11 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Dermatologic Exam, Week 12 · Worsened	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Dermatologic Exam, Week 24 · Improved	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Gastrointestinal Exam, Week 6 · Worsened	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Other Exam, Day 2 · No change	1 Participants	3 Participants	1 Participants	6 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Gastrointestinal Exam, Week 12 · Improved	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Gastrointestinal Exam, Week 12 · No change	4 Participants	4 Participants	4 Participants	11 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Gastrointestinal Exam, Week 12 · Worsened	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Gastrointestinal Exam, Week 24 · Improved	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Gastrointestinal Exam, Week 24 · No change	4 Participants	3 Participants	4 Participants	11 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Gastrointestinal Exam, Week 24 · Worsened	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Genitourinary Exam, Day 2 · Improved	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Genitourinary Exam, Day 2 · No change	4 Participants	5 Participants	4 Participants	11 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Genitourinary Exam, Day 2 · Worsened	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Genitourinary Exam, Day 16 · Improved	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Genitourinary Exam, Day 16 · No change	4 Participants	5 Participants	4 Participants	11 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Genitourinary Exam, Day 16 · Worsened	0 Participants	1 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Genitourinary Exam, Week 6 · Improved	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Genitourinary Exam, Week 6 · No change	4 Participants	4 Participants	4 Participants	11 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Genitourinary Exam, Week 6 · Worsened	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Genitourinary Exam, Week 12 · Improved	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Genitourinary Exam, Week 12 · No change	4 Participants	4 Participants	4 Participants	11 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Genitourinary Exam, Week 12 · Worsened	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Genitourinary Exam, Week 24 · Improved	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Genitourinary Exam, Week 24 · No change	4 Participants	3 Participants	4 Participants	11 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Genitourinary Exam, Week 24 · Worsened	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints HEENT Exam, Day 2 · Improved	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints HEENT Exam, Day 2 · No change	4 Participants	5 Participants	4 Participants	11 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints HEENT Exam, Day 2 · Worsened	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints HEENT Exam, Day 16 · Improved	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints HEENT Exam, Day 16 · No change	4 Participants	6 Participants	4 Participants	11 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints HEENT Exam, Day 16 · Worsened	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints HEENT Exam, Week 6 · Improved	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints HEENT Exam, Week 6 · No change	4 Participants	4 Participants	4 Participants	11 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints HEENT Exam, Week 6 · Worsened	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints HEENT Exam, Week 12 · Improved	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints HEENT Exam, Week 12 · No change	4 Participants	4 Participants	4 Participants	11 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints HEENT Exam, Week 12 · Worsened	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints HEENT Exam, Week 24 · Improved	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints HEENT Exam, Week 24 · No change	4 Participants	3 Participants	4 Participants	11 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints HEENT Exam, Week 24 · Worsened	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Lymphatic Exam, Day 2 · Improved	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Lymphatic Exam, Day 2 · No change	4 Participants	5 Participants	4 Participants	11 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Lymphatic Exam, Day 2 · Worsened	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Lymphatic Exam, Day 16 · Improved	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Lymphatic Exam, Day 16 · No change	4 Participants	6 Participants	4 Participants	11 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Lymphatic Exam, Day 16 · Worsened	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Lymphatic Exam, Week 6 · Improved	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Lymphatic Exam, Week 6 · No change	4 Participants	4 Participants	4 Participants	11 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Lymphatic Exam, Week 6 · Worsened	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Lymphatic Exam, Week 12 · Improved	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Lymphatic Exam, Week 12 · No change	4 Participants	4 Participants	4 Participants	11 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Lymphatic Exam, Week 12 · Worsened	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Lymphatic Exam, Week 24 · Improved	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Lymphatic Exam, Week 24 · No change	4 Participants	3 Participants	4 Participants	11 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Lymphatic Exam, Week 24 · Worsened	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Musculoskeletal Exam, Day 2 · Improved	0 Participants	1 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Musculoskeletal Exam, Day 2 · No change	4 Participants	4 Participants	3 Participants	11 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Musculoskeletal Exam, Day 2 · Worsened	0 Participants	0 Participants	1 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Musculoskeletal Exam, Day 16 · Improved	0 Participants	1 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Musculoskeletal Exam, Day 16 · No change	4 Participants	5 Participants	3 Participants	11 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Musculoskeletal Exam, Day 16 · Worsened	0 Participants	0 Participants	1 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Musculoskeletal Exam, Week 12 · Improved	0 Participants	0 Participants	0 Participants	1 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Musculoskeletal Exam, Week 12 · No change	4 Participants	3 Participants	3 Participants	10 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Musculoskeletal Exam, Week 12 · Worsened	0 Participants	1 Participants	1 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Musculoskeletal Exam, Week 6 · Improved	0 Participants	1 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Musculoskeletal Exam, Week 6 · No change	4 Participants	3 Participants	3 Participants	11 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Musculoskeletal Exam, Week 6 · Worsened	0 Participants	0 Participants	1 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Musculoskeletal Exam, Week 24 · Improved	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Musculoskeletal Exam, Week 24 · No change	4 Participants	3 Participants	3 Participants	11 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Musculoskeletal Exam, Week 24 · Worsened	0 Participants	0 Participants	1 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Neurological Exam, Day 2 · Improved	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Neurological Exam, Day 2 · No change	3 Participants	5 Participants	4 Participants	11 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Neurological Exam, Day 2 · Worsened	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Other Exam, Week 6 · Improved	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Neurological Exam, Day 16 · Improved	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Neurological Exam, Day 16 · No change	3 Participants	6 Participants	4 Participants	11 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Neurological Exam, Day 16 · Worsened	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Neurological Exam, Week 6 · Improved	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Other Exam, Day 2 · Worsened	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Neurological Exam, Week 6 · No change	3 Participants	4 Participants	4 Participants	11 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Neurological Exam, Week 6 · Worsened	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Neurological Exam, Week 12 · Improved	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Neurological Exam, Week 12 · No change	3 Participants	4 Participants	4 Participants	11 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Neurological Exam, Week 12 · Worsened	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Neurological Exam, Week 24 · Improved	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Neurological Exam, Week 24 · No change	3 Participants	3 Participants	4 Participants	11 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Other Exam, Day 16 · Improved	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Other Exam, Day 16 · No change	1 Participants	3 Participants	1 Participants	6 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Other Exam, Week 6 · No change	1 Participants	2 Participants	1 Participants	6 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Other Exam, Week 6 · Worsened	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Other Exam, Week 12 · Improved	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Neurological Exam, Week 24 · Worsened	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Other Exam, Day 2 · Improved	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Other Exam, Week 12 · No change	1 Participants	2 Participants	1 Participants	6 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Other Exam, Day 16 · Worsened	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Other Exam, Week 12 · Worsened	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Other Exam, Week 24 · Improved	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Pulmonary Exam, Day 16 · Improved	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Pulmonary Exam, Day 16 · No change	4 Participants	6 Participants	4 Participants	11 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Other Exam, Week 24 · No change	1 Participants	2 Participants	1 Participants	6 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Other Exam, Week 24 · Worsened	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Pulmonary Exam, Day 16 · Worsened	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Pulmonary Exam, Week 6 · Improved	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Pulmonary Exam, Week 6 · No change	4 Participants	4 Participants	4 Participants	11 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Pulmonary Exam, Day 2 · Improved	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Pulmonary Exam, Week 6 · Worsened	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Pulmonary Exam, Week 12 · Improved	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Pulmonary Exam, Week 12 · No change	4 Participants	4 Participants	4 Participants	11 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Pulmonary Exam, Day 2 · No change	4 Participants	5 Participants	4 Participants	11 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Pulmonary Exam, Week 12 · Worsened	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Pulmonary Exam, Day 2 · Worsened	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Pulmonary Exam, Week 24 · Improved	0 Participants	0 Participants	0 Participants	0 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Pulmonary Exam, Week 24 · No change	4 Participants	3 Participants	4 Participants	11 Participants
Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints Pulmonary Exam, Week 24 · Worsened	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

Cohort 1 - NOX66 400mg Daily

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Cohort 2 - NOX66 800mg Daily

Serious events: 3 serious events

Other events: 5 other events

Deaths: 3 deaths

Cohort 3 - NOX66 1200mg Daily

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Cohort 4 - NOX66 1200mg Daily

Serious events: 1 serious events

Other events: 9 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1 - NOX66 400mg Daily n=4 participants at risk NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 400mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 2 - NOX66 800mg Daily n=6 participants at risk NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 800mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 3 - NOX66 1200mg Daily n=4 participants at risk NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 1200mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 4 - NOX66 1200mg Daily n=11 participants at risk NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 1200mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.
Gastrointestinal disorders Nausea	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	16.7% 1/6 • Number of events 1 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/11 • Individual subjects = 9 months. Entire study = 19 months.
Gastrointestinal disorders Vomiting	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	16.7% 1/6 • Number of events 1 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/11 • Individual subjects = 9 months. Entire study = 19 months.
General disorders Disease Progression	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	50.0% 3/6 • Number of events 3 • Individual subjects = 9 months. Entire study = 19 months.	25.0% 1/4 • Number of events 1 • Individual subjects = 9 months. Entire study = 19 months.	9.1% 1/11 • Number of events 1 • Individual subjects = 9 months. Entire study = 19 months.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	16.7% 1/6 • Number of events 1 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/11 • Individual subjects = 9 months. Entire study = 19 months.

Other adverse events

Additional Information

Lorena Figueroa, Director clinical Operations

Noxopharm

Phone: +612 9144 2223

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 120 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Publication restrictions are in place

Restriction type: OTHER

Measure	Cohort 1 - NOX66 400mg Daily n=4 participants at risk NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 400mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 2 - NOX66 800mg Daily n=6 participants at risk NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 800mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 3 - NOX66 1200mg Daily n=4 participants at risk NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 1200mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.	Cohort 4 - NOX66 1200mg Daily n=11 participants at risk NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose of 1200mg daily. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts. NOX66: NOX66 delivered as rectal suppository. Irradiation Therapy: Radiation per selected tumour lesion.
Blood and lymphatic system disorders Anaemia	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	33.3% 2/6 • Number of events 4 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	63.6% 7/11 • Number of events 12 • Individual subjects = 9 months. Entire study = 19 months.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	16.7% 1/6 • Number of events 1 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/11 • Individual subjects = 9 months. Entire study = 19 months.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	16.7% 1/6 • Number of events 1 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/11 • Individual subjects = 9 months. Entire study = 19 months.
Cardiac disorders Sinus arrhythmia	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/6 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	9.1% 1/11 • Number of events 1 • Individual subjects = 9 months. Entire study = 19 months.
Gastrointestinal disorders Constipation	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	16.7% 1/6 • Number of events 1 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	9.1% 1/11 • Number of events 1 • Individual subjects = 9 months. Entire study = 19 months.
Gastrointestinal disorders Dry mouth	25.0% 1/4 • Number of events 1 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/6 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/11 • Individual subjects = 9 months. Entire study = 19 months.
Gastrointestinal disorders Epigastric discomfort	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	16.7% 1/6 • Number of events 1 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/11 • Individual subjects = 9 months. Entire study = 19 months.
Gastrointestinal disorders Nausea	25.0% 1/4 • Number of events 1 • Individual subjects = 9 months. Entire study = 19 months.	16.7% 1/6 • Number of events 1 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/11 • Individual subjects = 9 months. Entire study = 19 months.
Gastrointestinal disorders Stomatitis	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	16.7% 1/6 • Number of events 1 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/11 • Individual subjects = 9 months. Entire study = 19 months.
General disorders Asthenia	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/6 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	9.1% 1/11 • Number of events 1 • Individual subjects = 9 months. Entire study = 19 months.
General disorders Fatigue	25.0% 1/4 • Number of events 1 • Individual subjects = 9 months. Entire study = 19 months.	16.7% 1/6 • Number of events 1 • Individual subjects = 9 months. Entire study = 19 months.	25.0% 1/4 • Number of events 1 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/11 • Individual subjects = 9 months. Entire study = 19 months.
General disorders Pain	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	33.3% 2/6 • Number of events 2 • Individual subjects = 9 months. Entire study = 19 months.	25.0% 1/4 • Number of events 1 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/11 • Individual subjects = 9 months. Entire study = 19 months.
Infections and infestations Infected cyst	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	16.7% 1/6 • Number of events 1 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/11 • Individual subjects = 9 months. Entire study = 19 months.
Infections and infestations Urinary tract infection	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	33.3% 2/6 • Number of events 3 • Individual subjects = 9 months. Entire study = 19 months.	25.0% 1/4 • Number of events 2 • Individual subjects = 9 months. Entire study = 19 months.	54.5% 6/11 • Number of events 12 • Individual subjects = 9 months. Entire study = 19 months.
Injury, poisoning and procedural complications Radiation skin injury	25.0% 1/4 • Number of events 1 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/6 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/11 • Individual subjects = 9 months. Entire study = 19 months.
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/6 • Individual subjects = 9 months. Entire study = 19 months.	25.0% 1/4 • Number of events 1 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/11 • Individual subjects = 9 months. Entire study = 19 months.
Investigations Blood alkaline phosphatase increased	25.0% 1/4 • Number of events 1 • Individual subjects = 9 months. Entire study = 19 months.	16.7% 1/6 • Number of events 1 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/11 • Individual subjects = 9 months. Entire study = 19 months.
Investigations Blood lactate dehydrogenase increased	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	16.7% 1/6 • Number of events 1 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/11 • Individual subjects = 9 months. Entire study = 19 months.
Investigations Gamma-glutamyltransferase increased	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	16.7% 1/6 • Number of events 1 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/11 • Individual subjects = 9 months. Entire study = 19 months.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	16.7% 1/6 • Number of events 1 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/11 • Individual subjects = 9 months. Entire study = 19 months.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	16.7% 1/6 • Number of events 1 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	9.1% 1/11 • Number of events 1 • Individual subjects = 9 months. Entire study = 19 months.
Metabolism and nutrition disorders Hypocalcaemia	25.0% 1/4 • Number of events 1 • Individual subjects = 9 months. Entire study = 19 months.	33.3% 2/6 • Number of events 4 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	27.3% 3/11 • Number of events 3 • Individual subjects = 9 months. Entire study = 19 months.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	16.7% 1/6 • Number of events 1 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	9.1% 1/11 • Number of events 1 • Individual subjects = 9 months. Entire study = 19 months.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	16.7% 1/6 • Number of events 2 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/11 • Individual subjects = 9 months. Entire study = 19 months.
Musculoskeletal and connective tissue disorders Back pain	25.0% 1/4 • Number of events 1 • Individual subjects = 9 months. Entire study = 19 months.	33.3% 2/6 • Number of events 3 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	45.5% 5/11 • Number of events 6 • Individual subjects = 9 months. Entire study = 19 months.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/6 • Individual subjects = 9 months. Entire study = 19 months.	25.0% 1/4 • Number of events 1 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/11 • Individual subjects = 9 months. Entire study = 19 months.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/6 • Individual subjects = 9 months. Entire study = 19 months.	25.0% 1/4 • Number of events 1 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/11 • Individual subjects = 9 months. Entire study = 19 months.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	16.7% 1/6 • Number of events 1 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/11 • Individual subjects = 9 months. Entire study = 19 months.
Musculoskeletal and connective tissue disorders Spinal pain	25.0% 1/4 • Number of events 1 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/6 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	18.2% 2/11 • Number of events 2 • Individual subjects = 9 months. Entire study = 19 months.
Nervous system disorders Lethargy	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	16.7% 1/6 • Number of events 1 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/11 • Individual subjects = 9 months. Entire study = 19 months.
Psychiatric disorders Anxiety	25.0% 1/4 • Number of events 1 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/6 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/11 • Individual subjects = 9 months. Entire study = 19 months.
Psychiatric disorders Delirium	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	16.7% 1/6 • Number of events 1 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/11 • Individual subjects = 9 months. Entire study = 19 months.
Psychiatric disorders Depression	25.0% 1/4 • Number of events 1 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/6 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/11 • Individual subjects = 9 months. Entire study = 19 months.
Renal and urinary disorders Haematuria	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/6 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	9.1% 1/11 • Number of events 1 • Individual subjects = 9 months. Entire study = 19 months.
Renal and urinary disorders Urinary retention	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/6 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	9.1% 1/11 • Number of events 1 • Individual subjects = 9 months. Entire study = 19 months.
Reproductive system and breast disorders Pelvic pain	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/6 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	9.1% 1/11 • Number of events 1 • Individual subjects = 9 months. Entire study = 19 months.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/6 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	18.2% 2/11 • Number of events 2 • Individual subjects = 9 months. Entire study = 19 months.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/6 • Individual subjects = 9 months. Entire study = 19 months.	25.0% 1/4 • Number of events 1 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/11 • Individual subjects = 9 months. Entire study = 19 months.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/6 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	9.1% 1/11 • Number of events 1 • Individual subjects = 9 months. Entire study = 19 months.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/6 • Individual subjects = 9 months. Entire study = 19 months.	25.0% 1/4 • Number of events 1 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/11 • Individual subjects = 9 months. Entire study = 19 months.
Vascular disorders Hot flush	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	16.7% 1/6 • Number of events 2 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/4 • Individual subjects = 9 months. Entire study = 19 months.	0.00% 0/11 • Individual subjects = 9 months. Entire study = 19 months.