Safety and Tolerability of NOX66 in Combination With Pall... | NCT03307629

NCT03307629

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NOX66 + Radiation treatment (combined) in cohorts 1-3	Experimental	NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 treatment given to 3 cohorts of 4 patients as 1 of 3 doses, 400mg, 800mg and 1200 mg. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts.	Drug: NOX66 Radiation: Irradiation Therapy
NOX66 + Radiation treatment (combined) in cohort 4	Experimental	NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle. NOX66 dose will be either one of 3 doses 400mg, 800mg and 1200 mg based on interim analyses of safety data and tumour response at WEEK 6 of 3 dose cohorts of 12 total patients. The Safety Steering Committee will inform on dose for cohort expansion. Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts.	Drug: NOX66 Radiation: Irradiation Therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NOX66	Drug	NOX66 delivered as rectal suppository.	NOX66 + Radiation treatment (combined) in cohort 4 NOX66 + Radiation treatment (combined) in cohorts 1-3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Treatment-Emergent Adverse Events Including SAEs [Safety and Tolerability] of NOX66 Combined With Radiation Therapy at Multiple Timepoints	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.	Day 2, Day 6, EOT (Day 16), Week 6, Week 12, and Week 24
Assessment of Laboratory Results	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.	From Baseline to End of Treatment (Day 16), Week 6, Week 12, and Week 24.
Assessment of ECG Results	Mean change from Baseline in ECG intervals (msec) which are assessed at End of treatment (Day 16), Week 12, and Week 24.	Baseline to End of treatment (Day 16), Week 12, and Week 24.

Secondary Outcomes

Measure	Description	Time Frame
Change of Target Lesions in Participants According to RECIST 1.1 Criteria	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.	Week 6, Week 12, and Week 24

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Provision of informed consent
≥ 18 years of age
Histologically confirmed prostate cancer and/or PSA of >100 ng/mL at original diagnosis
Metastatic disease evidenced by either CT/MRI imaging or bone scan
Objective evidence of disease progression as defined by either:

i. Radiographic progression of in nodal or visceral metastases and bone disease progression with 2 or more new lesions ii. Rising PSA value ≥2ng/ml in at least 3 measurements, at least 1 week apart, with castrate levels of serum testosterone.
Eligible to receive palliative radiation therapy for management of disease
At least one symptomatic lesion which is suitable for radiation therapy
ECOG Performance status 0-2
A minimum life expectancy of 24 weeks
Adequate bone marrow, hepatic and renal function as evidenced by:
- Absolute neutrophil count (ANC) > 1.5 x 109/L
- Platelet count > 100 x 109/L
- Hemoglobin > 9.0 g/dL
- Serum bilirubin < 1.5 x ULN
- AST/ALT (SGOT/SGPT) < 2.5 x ULN for the reference laboratory or < 5 x ULN in the presence of liver metastases
- Serum creatinine < 1.5 x ULN
Ongoing androgen deprivation therapy with luteinizing hormone-releasing hormone (LHRH) agonist or antagonist
At least 4 weeks must have elapsed prior to commencement of NOX66 treatment since prior chemotherapy, investigational drug or biologic therapy and any toxicity associated with these treatments has recovered to ≤ NCI-CTCAE (version 4.03) Grade 1.
At least 21 days must have elapsed following major surgery and any surgical incision should be completely healed.

Exclusion Criteria:

Tumour involvement of the central nervous system
Uncontrolled infection or systemic disease
Clinically significant cardiac disease not well controlled with medication (e.g. congestive heart failure, symptomatic coronary artery disease, angina, and cardiac arrhythmias) or myocardial infarction within the last 12 months

• Patients with a QTc > 470 msec on screening ECG
Concurrent systemic chemotherapy or biological therapy
Any situation where the use of suppository therapy is contra-indicated or impractical (eg. chronic diarrhoea, colostomy, ulcerative colitis).
Known human immunodeficiency virus (HIV) or Hepatitis B or C (active, previously treated or both)
Any subject whose testosterone is not suppressed i.e. is > 0.5nmols/L
Any other reason which, in the opinion of the investigator, will preclude suitable participation in the study.

Contacts/Locations Module

Name	Affiliation	Role
Marinella Messina, PhD	Noxopharm Limited	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Genesis Cancer Care - Newcastle		Newcastle	New South Wales	2290	Australia
Central West Cancer Care Centre - Orange Health Service

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jul 11, 2019

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	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.
BG002	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.
BG003	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 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.
BG004	Total	Total of all reporting groups

Units	Counts
Participants	BG0004 BG0016 BG0024 BG00311 BG00425

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00072.8± 8.06 BG00168.5± 3.73 BG00268.6± 5.25 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0000 BG0010 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

New Zealand

Title	Measurements
	BG0000 BG0010 BG002

Diagnostic PSA level

Mean

Standard Deviation

ng/mL

Title

Denominators

Categories

Title	Measurements
	BG000560.00± 579.828 BG001222.38± 123.755 BG002

ECOG Performance Status at Screening

Count of Participants

Participants

Title

Denominators

Categories

0 (Fully active)

Title	Measurements
	BG0000 BG0010 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Treatment-Emergent Adverse Events Including SAEs [Safety and Tolerability] of NOX66 Combined With Radiation Therapy at Multiple Timepoints

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.

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.
OG003	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 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.

Units	Counts
Participants	OG0004 OG0016 OG0024 OG003

Title

Denominators

Categories

Adverse events (AEs)

Title	Measurements
	OG0004 OG0015 OG0022 OG003

Primary

Assessment of Laboratory Results

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.

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

Posted

Mean

Standard Deviation

micromol/L

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

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

Primary

Assessment of ECG Results

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

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

Posted

Mean

Standard Deviation

msec

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

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

Primary

Assessment of Laboratory Results

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.

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

Posted

Mean

Standard Deviation

(g/L

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

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

Primary

Assessment of Laboratory Results

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.

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

Posted

Mean

Standard Deviation

Percetange

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

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

Primary

Assessment of Laboratory Results

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.

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

Posted

Mean

Standard Deviation

10^9cells/L

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

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

Primary

Assessment of Laboratory Results

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.

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

Posted

Mean

Standard Deviation

10^12cells/L

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

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

Primary

Assessment of Laboratory Results

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.

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

Posted

Mean

Standard Deviation

U/L

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

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

Primary

Assessment of Laboratory Results

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.

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

Posted

Mean

Standard Deviation

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

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

Primary

Assessment of Laboratory Results

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.

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

Posted

Mean

Standard Deviation

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

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

Secondary

Change of Target Lesions in Participants According to RECIST 1.1 Criteria

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.

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

Posted

Count of Participants

Participants

Week 6, Week 12, and Week 24

ID	Title	Description
OG000	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.
OG001	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.
OG002

Secondary

Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria

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.

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

Posted

Count of Participants

Participants

Week 6, Week 12, and Week 24

ID	Title	Description
OG000	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.
OG001	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.
OG002	Cohort 3 - NOX66 1200mg Daily

Secondary

Overall Response According to RECIST 1.1 Criteria

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)

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	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.
OG001	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.
OG002	Cohort 3 - NOX66 1200mg Daily

Secondary

Change in Overall Pain Score Using the Brief Pain Inventory - Short Form (BPI-SF)

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.

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

Posted

Mean

Standard Deviation

Percentage change from baseline in score

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

ID	Title	Description
OG000	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.
OG001	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.
OG002	Cohort 3 - NOX66 1200mg Daily

Secondary

Change in Prostate Specific Antigen (PSA) Levels

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

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

Posted

Mean

Standard Deviation

Percentage change from baseline in PSA

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

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

Secondary

Change of ECOG Performance Status

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

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

Secondary

Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints

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.

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	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.
OG001	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.

Primary

Assessment of Laboratory Results

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.

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

Posted

Mean

Standard Deviation

mmol/L

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

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.	0	4	0	4	4	4
EG001	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.	3	6	3	6	5	6
EG002	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.	0	4	1	4	2	4
EG003	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 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.	1	11	1	11	9	11

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected6 at risk EG0020 events0 affected4 at risk EG0030 events0 affected11 at risk
Vomiting	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Disease Progression	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected4 at risk EG0013 events3 affected6 at risk EG0021 events1 affected4 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected6 at risk EG0020 events0 affected4 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected4 at risk EG0014 events2 affected6 at risk EG0020 events0 affected4 at risk EG00312 events7 affected11 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Sinus arrhythmia	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Epigastric discomfort	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected4 at risk EG0011 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Asthenia	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Fatigue	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected4 at risk EG0011 events1 affected6 at risk EG0021 events1 affected4 at risk EG003
Pain	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected4 at risk EG0012 events2 affected6 at risk EG0021 events1 affected4 at risk EG003
Infected cyst	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected4 at risk EG0013 events2 affected6 at risk EG0022 events1 affected4 at risk EG003
Radiation skin injury	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected6 at risk EG0021 events1 affected4 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected4 at risk EG0011 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Blood lactate dehydrogenase increased	Investigations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected4 at risk EG0014 events2 affected6 at risk EG0020 events0 affected4 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected4 at risk EG0012 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected4 at risk EG0013 events2 affected6 at risk EG0020 events0 affected4 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected6 at risk EG0021 events1 affected4 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected6 at risk EG0021 events1 affected4 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Lethargy	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Anxiety	Psychiatric disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Delirium	Psychiatric disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Depression	Psychiatric disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Pelvic pain	Reproductive system and breast disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected6 at risk EG0021 events1 affected4 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected6 at risk EG0021 events1 affected4 at risk EG003
Hot flush	Vascular disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected4 at risk EG0012 events1 affected6 at risk EG0020 events0 affected4 at risk EG003

ID	Term
D009369	Neoplasms

BG003154.0± 101.402

BG004321.92± 258.950

Title	Measurements
	OG00033.9± 68.59 OG0014.8± 13.62 OG002-7± 23.67 OG0037.6± 36.6

Title	Measurements
	OG0009.7± 34.76 OG0014.8± 27.69 OG0025.2± 25.62 OG0039.2± 12.55

Title	Measurements
	OG00019± 48.92 OG00119.7± 32.1 OG00211.1± 8.12 OG00317.9± 40.32

Title	Measurements
	OG00029.5± 30.88 OG00117.0± 24.99 OG00212.7± 6.39 OG00315± 25.5

Title	Measurements
	OG00023.3± 29.57 OG001-2.6± 14.34 OG0026.1± 11.55 OG0030.8± 16.61

Title	Measurements
	OG00023.4± 50.15 OG001-56.4± 123.08 OG0027.6± 66.68 OG0034.5± 212.55

Title	Measurements
	OG00035.1± 201.4 OG001-11.6± 150.02 OG002-55.6± 140.05 OG003-20.1± 181.42

Title	Measurements
	OG000-54.4± 82.71 OG00131.8± 59.97 OG002-17.2± 112.8 OG00339.5± 38.78

Title	Measurements
	OG000-7.25± 13.598 OG001-8.50± 17.540 OG002-4.75± 10.532 OG003-11.27± 8.810

Title	Measurements
	OG00011.00± 14.855 OG0014.75± 21.140 OG002-6.00± 6.083 OG003-7.45± 15.247

Title	Measurements
	OG0003.50± 6.608 OG001-2.00± 21.932 OG002-4.25± 6.397 OG003-14.60± 23.341

Title	Measurements
	OG0000.80± 7.532 OG001-1.88± 5.518 OG0020.34± 4.418 OG003-0.63± 4.785

Title	Measurements
	OG000-1.68± 2.538 OG0014.58± 8.423 OG002-0.66± 7.579 OG003-3.88± 7.482

Title	Measurements
	OG0000.10± 2.761 OG0013.77± 8.070 OG002-1.01± 9.782 OG003-1.84± 5.678

Title	Measurements
	OG000-0.78± 3.497 OG0013.77± 8.070 OG002-2.60± 8.497 OG0030.58± 5.053

Title	Measurements
	OG0004.52± 6.700 OG0010.36± 7.813 OG002-0.08± 7.023 OG0030.23± 5.626

Title	Measurements
	OG0004.04± 10.150 OG0015.36± 7.813 OG002-0.08± 7.023 OG003-2.59± 9.247

Title	Measurements
	OG0003.63± 5.397 OG0017.44± 12.707 OG0020.27± 15.883 OG003-0.68± 6.808

Title	Measurements
	OG0001.43± 4.742 OG0015.15± 14.853 OG002-2.68± 13.654 OG0030.15± 6.919

Title	Measurements
	OG0000.83± 1.489 OG001-2.23± 5.229 OG002-1.58± 3.040 OG003-3.25± 2.924

Title	Measurements
	OG0006.83± 1.489 OG001-2.23± 5.229 OG002-1.58± 3.040 OG003-3.25± 2.924

Title	Measurements
	OG0003.48± 5.067 OG001-0.40± 6.391 OG002-1.28± 2.313 OG003-4.42± 5.966

Title	Measurements
	OG000-81.50± 49.143 OG001-60.50± 86.002 OG00283.00± 95.781 OG003-17.09± 58.066

Title	Measurements
	OG000-60.0± 101.278 OG00136.25± 182.967 OG002-8.33± 129.894 OG00328.36± 73.595

Title	Measurements
	OG00086.75± 54.872 OG001-74.00± 65.818 OG00234.75± 141.354 OG0030.20± 79.998

Title	Measurements
	OG000-0.57± 0.675 OG001-0.41± 0.770 OG0020.35± 0.710 OG003-0.66± 1.113

Title	Measurements
	OG0000.44± 0.497 OG001-0.75± 0.838 OG0020.46± 0.901 OG003-0.39± 1.238

Title	Measurements
	OG000-0.38± 0.682 OG001-0.29± 0.792 OG0020.24± 1.279 OG003-0.34± 1.175

Title	Measurements
	OG000-0.45± 0.768 OG001-1.25± 0.670 OG0020.05± 0.854 OG003-0.71± 1.761

Title	Measurements
	OG000-0.02± 1.396 OG0011.38± 1.926 OG0021.47± 1.683 OG003-1.85± 1.926

Title	Measurements
	OG000-2.27± 0.641 OG001-0.77± 0.780 OG0022.76± 1.050 OG003-1.50± 1.906

Title	Measurements
	OG000-2.00± 1.956 OG0010.83± 1.466 OG0024.27± 3.309 OG003-1.03± 2.245

Title	Measurements
	OG000-1.50± 0.776 OG0010.11± 0.896 OG0022.47± 2.607 OG003-2.33± 2.571

Title	Measurements
	OG000-0.39± 0.623 OG0010.19± 0.130 OG0020.25± 0.200 OG003-0.06± 0.315

Title	Measurements
	OG000-0.42± 0622 OG001-0.13± 0.108 OG0020.15± 0.137 OG003-0.05± 0.359

Title	Measurements
	OG000-0.55± 0.629 OG0010.02± 0.310 OG0020.12± 0.827 OG0030.05± 0.396

Title	Measurements
	OG000-0.42± 0.565 OG001-0.11± 0.210 OG0020.13± 0.541 OG0030.29± 0.473

Title	Measurements
	OG0000.00± 0.081 OG0010.02± 0122 OG0020.05± 0.097 OG0030.05± 0.293

Title	Measurements
	OG0000.01± 0.059 OG0010.06± 0.120 OG0020.04± 0.162 OG003-0.06± 0.176

Title	Measurements
	OG0000.00± 0.081 OG0010.04± 0.333 OG002-0.02± 0.076 OG003-0.07± 0.090

Title	Measurements
	OG000-0.02± 0.042 OG001-0.09± 0.148 OG0020.00± 0.105 OG003-0.06± 0.119

Title	Measurements
	OG000-0.01± 0.010 OG001-0.01± 0.020 OG0020.00± 0.006 OG0030.00± 0.023

Title	Measurements
	OG0000.30± 0.632 OG001-0.01± 0.010 OG0020.02± 0.029 OG0030.01± 0.019

Title	Measurements
	OG0000.00± 0.005 OG0010.03± 0.066 OG0020.00± 0.006 OG0030.00± 0.013

Title	Measurements
	OG000-0.01± 0.033 OG001-0.02± 0.006 OG0020.00± 0.000 OG003-0.01± 0.020

Title	Measurements
	OG000228.28± 230.132 OG001-95.55± 193.289 OG0023.60± 31.794 OG003-11.73± 184.158

Title	Measurements
	OG000261.98± 220.518 OG001-142.00± 225.295 OG002-17.00± 7.791 OG003144.01± 250.644

Title	Measurements
	OG000271.30± 172.254 OG001-167.33± 328.804 OG002-16.10± 12.928 OG003-26.66± 27.916

Title	Measurements
	OG0000.56± 2.380 OG0010.02± 13.231 OG0020.13± 2.347 OG003-0.65± 8.070

Title	Measurements
	OG0000.93± 3.621 OG001-1.24± 4.199 OG002-0.28± 6.779 OG0030.00± 8.286

Title	Measurements
	OG0000.40± 2.637 OG001-5.93± 15.796 OG002-1.80± 6.948 OG003-4.58± 11.113

Title	Measurements
	OG000-0.96± 1.077 OG0010.56± 4.801 OG002-0.85± 2.420 OG003-1.11± 2.961

Title	Measurements
	OG0002.14± 0.869 OG0015.87± 6.867 OG0020.00± 0.000 OG003-4.59± 9.102

Title	Measurements
	OG0005.24± 6.508 OG0010.74± 2.413 OG0021.08± 2.045 OG003-4.87± 6.70

Title	Measurements
	OG0002.14± 1.919 OG001-1.26± 5.592 OG0024.03± 1.861 OG0035.03± 23.916

Title	Measurements
	OG0006.64± 6.137 OG001-3.42± 8.199 OG002-0.78± 2.382 OG003-2.08± 3.281

Title	Measurements
	OG000-58.954± 40.1178 OG001-47.815± 35.0069 OG002-44.1± 44.36 OG003-41.8± 42.28

Title	Measurements
	OG000-55.830± 52.9611 OG001-29.175± 82.3088 OG00242.8± 44.46 OG003-37.0± 47.51

Title	Measurements
	OG00010.786± 46.4994 OG001-80.992± 32.9233 OG002-38.4± 35.16 OG003-68.6± 49.04

Title	Measurements
	OG00035.75± 31.610 OG001-53.26± 31.766 OG00214.82± 138.637 OG003-310± 73.373

Title	Measurements
	OG000333.51± 357.538 OG001-14.85± 62.764 OG002374.20± 518.309 OG00364.86± 195.334

Title	Measurements
0 (Fully active)	OG0000 OG0011 OG0022 OG0031
1 (Ambulatory; No strenuous activity)	OG0004 OG0013 OG0021 OG0037
2 (Ambulatory; No work activity)	OG0000 OG0010 OG0021 OG0033
3 (Limited self-care)	OG0000 OG0010 OG0020 OG0030
4 (No self-care)	OG0000 OG0010 OG0020 OG0030
5 (Dead)	OG0000 OG0010 OG0020 OG0030

Title	Measurements
0 (Fully active)	OG0000 OG0012 OG0022 OG0032
1 (Ambulatory; No strenuous activity)	OG0004 OG0011 OG0021 OG0035
2 (Ambulatory; No work activity)	OG0000 OG0011 OG0020 OG0032
3 (Limited self-care)	OG0000 OG0010 OG0020 OG0031
4 (No self-care)	OG0000 OG0010 OG0020 OG0031
5 (Dead)	OG0000 OG0010 OG0020 OG0030

Title	Measurements
0 (Fully active)	OG0000 OG0012 OG0022 OG0032
1 (Ambulatory; No strenuous activity)	OG0003 OG0011 OG0021 OG0031
2 (Ambulatory; No work activity)	OG0001 OG0010 OG0020 OG0031
3 (Limited self-care)	OG0000 OG0010 OG0021 OG0031
4 (No self-care)	OG0000 OG0010 OG0020 OG0030
5 (Dead)	OG0000 OG0011 OG0020 OG0030

Title	Measurements
Improved	OG0000 OG0010 OG0020 OG0030
No change	OG0004 OG0016 OG0024 OG00311
Worsened	OG0000 OG0010 OG0020 OG0030

Title	Measurements
Improved	OG0000 OG0010 OG0020 OG0030
No change	OG0004 OG0014 OG0024 OG00311
Worsened	OG0000 OG0010 OG0020 OG0030

Title	Measurements
Improved	OG0000 OG0010 OG0020 OG0030
No change	OG0004 OG0014 OG0024 OG00311
Worsened	OG0000 OG0010 OG0020 OG0030

Title	Measurements
Improved	OG0000 OG0010 OG0020 OG0030
No change	OG0004 OG0013 OG0024 OG00311
Worsened	OG0000 OG0010 OG0020 OG0030

Title	Measurements
Improved	OG0000 OG0010 OG0020 OG0030
No change	OG0004 OG0015 OG0024 OG00311
Worsened	OG0000 OG0010 OG0020 OG0030

Title	Measurements
Improved	OG0000 OG0010 OG0020 OG0030
No change	OG0004 OG0016 OG0024 OG00311
Worsened	OG0000 OG0010 OG0020 OG0030

Title	Measurements
Improved	OG0000 OG0010 OG0020 OG0030
No change	OG0004 OG0014 OG0024 OG00311
Worsened	OG0000 OG0010 OG0020 OG0030

Title	Measurements
Improved	OG0000 OG0010 OG0020 OG0030
No change	OG0004 OG0014 OG0024 OG00311
Worsened	OG0000 OG0010 OG0020 OG0030

Title	Measurements
Improved	OG0000 OG0010 OG0020 OG0030
No change	OG0004 OG0013 OG0024 OG00311
Worsened	OG0000 OG0010 OG0020 OG0030

Title	Measurements
Improved	OG0000 OG0010 OG0020 OG0030
No change	OG0004 OG0015 OG0024 OG00311
Worsened	OG0000 OG0010 OG0020 OG0030

Title	Measurements
Improved	OG0000 OG0010 OG0020 OG0030
No change	OG0004 OG0015 OG0024 OG00311
Worsened	OG0000 OG0011 OG0020 OG0030

Title	Measurements
Improved	OG0000 OG0010 OG0020 OG0030
No change	OG0004 OG0014 OG0024 OG00311
Worsened	OG0000 OG0010 OG0020 OG0030

Title	Measurements
Improved	OG0000 OG0010 OG0020 OG0030
No change	OG0004 OG0014 OG0024 OG00311
Worsened	OG0000 OG0010 OG0020 OG0030

Title	Measurements
Improved	OG0000 OG0010 OG0020 OG0030
No change	OG0004 OG0013 OG0024 OG00311
Worsened	OG0000 OG0010 OG0020 OG0030

Title	Measurements
Improved	OG0000 OG0010 OG0020 OG0030
No change	OG0004 OG0014 OG0024 OG00311
Worsened	OG0000 OG0011 OG0020 OG0030

Title	Measurements
Improved	OG0000 OG0010 OG0020 OG0030
No change	OG0004 OG0015 OG0024 OG00311
Worsened	OG0000 OG0011 OG0020 OG0030

Title	Measurements
Improved	OG0000 OG0010 OG0020 OG0030
No change	OG0004 OG0014 OG0024 OG00311
Worsened	OG0000 OG0010 OG0020 OG0030

Title	Measurements
Improved	OG0000 OG0010 OG0020 OG0030
No change	OG0004 OG0015 OG0024 OG00311
Worsened	OG0000 OG0010 OG0020 OG0030

Title	Measurements
Improved	OG0000 OG0010 OG0020 OG0030
No change	OG0004 OG0015 OG0024 OG00311
Worsened	OG0000 OG0011 OG0020 OG0030

Title	Measurements
Improved	OG0000 OG0010 OG0020 OG0030
No change	OG0004 OG0014 OG0024 OG00311
Worsened	OG0000 OG0010 OG0020 OG0030

Title	Measurements
Improved	OG0000 OG0010 OG0020 OG0030
No change	OG0004 OG0014 OG0024 OG00311
Worsened	OG0000 OG0010 OG0020 OG0030

Title	Measurements
Improved	OG0000 OG0010 OG0020 OG0030
No change	OG0004 OG0013 OG0024 OG00311
Worsened	OG0000 OG0010 OG0020 OG0030

Title	Measurements
Improved	OG0000 OG0010 OG0020 OG0030
No change	OG0004 OG0015 OG0024 OG00311
Worsened	OG0000 OG0010 OG0020 OG0030

Title	Measurements
Improved	OG0000 OG0010 OG0020 OG0030
No change	OG0004 OG0016 OG0024 OG00311
Worsened	OG0000 OG0010 OG0020 OG0030

Title	Measurements
Improved	OG0000 OG0010 OG0020 OG0030
No change	OG0004 OG0014 OG0024 OG00311
Worsened	OG0000 OG0010 OG0020 OG0030

Title	Measurements
Improved	OG0000 OG0010 OG0020 OG0030
No change	OG0004 OG0014 OG0024 OG00311
Worsened	OG0000 OG0010 OG0020 OG0030

Title	Measurements
Improved	OG0000 OG0010 OG0020 OG0030
No change	OG0004 OG0013 OG0024 OG00311
Worsened	OG0000 OG0010 OG0020 OG0030

Title	Measurements
Improved	OG0000 OG0010 OG0020 OG0030
No change	OG0004 OG0015 OG0024 OG00311
Worsened	OG0000 OG0010 OG0020 OG0030

Title	Measurements
Improved	OG0000 OG0010 OG0020 OG0030
No change	OG0004 OG0016 OG0024 OG00311
Worsened	OG0000 OG0010 OG0020 OG0030

Title	Measurements
Improved	OG0000 OG0010 OG0020 OG0030
No change	OG0004 OG0014 OG0024 OG00311
Worsened	OG0000 OG0010 OG0020 OG0030

Title	Measurements
Improved	OG0000 OG0010 OG0020 OG0030
No change	OG0004 OG0014 OG0024 OG00311
Worsened	OG0000 OG0010 OG0020 OG0030

Title	Measurements
Improved	OG0000 OG0010 OG0020 OG0030
No change	OG0004 OG0013 OG0024 OG00311
Worsened	OG0000 OG0010 OG0020 OG0030

Title	Measurements
Improved	OG0000 OG0011 OG0020 OG0030
No change	OG0004 OG0014 OG0023 OG00311
Worsened	OG0000 OG0010 OG0021 OG0030

Title	Measurements
Improved	OG0000 OG0011 OG0020 OG0030
No change	OG0004 OG0015 OG0023 OG00311
Worsened	OG0000 OG0010 OG0021 OG0030

Title	Measurements
Improved	OG0000 OG0010 OG0020 OG0031
No change	OG0004 OG0013 OG0023 OG00310
Worsened	OG0000 OG0011 OG0021 OG0030

Title	Measurements
Improved	OG0000 OG0011 OG0020 OG0030
No change	OG0004 OG0013 OG0023 OG00311
Worsened	OG0000 OG0010 OG0021 OG0030

Title	Measurements
Improved	OG0000 OG0010 OG0020 OG0030
No change	OG0004 OG0013 OG0023 OG00311
Worsened	OG0000 OG0010 OG0021 OG0030

Title	Measurements
Improved	OG0000 OG0010 OG0020 OG0030
No change	OG0003 OG0015 OG0024 OG00311
Worsened	OG0000 OG0010 OG0020 OG0030

Title	Measurements
Improved	OG0000 OG0010 OG0020 OG0030
No change	OG0003 OG0016 OG0024 OG00311
Worsened	OG0000 OG0010 OG0020 OG0030

Title	Measurements
Improved	OG0000 OG0010 OG0020 OG0030
No change	OG0003 OG0014 OG0024 OG00311
Worsened	OG0000 OG0010 OG0020 OG0030

Title	Measurements
Improved	OG0000 OG0010 OG0020 OG0030
No change	OG0003 OG0014 OG0024 OG00311
Worsened	OG0000 OG0010 OG0020 OG0030

Title	Measurements
Improved	OG0000 OG0010 OG0020 OG0030
No change	OG0003 OG0013 OG0024 OG00311
Worsened	OG0000 OG0010 OG0020 OG0030

Title	Measurements
Improved	OG0000 OG0010 OG0020 OG0030
No change	OG0001 OG0013 OG0021 OG0036
Worsened	OG0000 OG0010 OG0020 OG0030

Title	Measurements
Improved	OG0000 OG0010 OG0020 OG0030
No change	OG0001 OG0013 OG0021 OG0036
Worsened	OG0000 OG0010 OG0020 OG0030

Title	Measurements
Improved	OG0000 OG0010 OG0020 OG0030
No change	OG0001 OG0012 OG0021 OG0036
Worsened	OG0000 OG0010 OG0020 OG0030

Title	Measurements
Improved	OG0000 OG0010 OG0020 OG0030
No change	OG0001 OG0012 OG0021 OG0036
Worsened	OG0000 OG0010 OG0020 OG0030

Title	Measurements
Improved	OG0000 OG0010 OG0020 OG0030
No change	OG0001 OG0012 OG0021 OG0036
Worsened	OG0000 OG0010 OG0020 OG0030

Title	Measurements
Improved	OG0000 OG0010 OG0020 OG0030
No change	OG0004 OG0015 OG0024 OG00311
Worsened	OG0000 OG0010 OG0020 OG0030

Title	Measurements
Improved	OG0000 OG0010 OG0020 OG0030
No change	OG0004 OG0016 OG0024 OG00311
Worsened	OG0000 OG0010 OG0020 OG0030

Title	Measurements
Improved	OG0000 OG0010 OG0020 OG0030
No change	OG0004 OG0014 OG0024 OG00311
Worsened	OG0000 OG0010 OG0020 OG0030

Title	Measurements
Improved	OG0000 OG0010 OG0020 OG0030
No change	OG0004 OG0014 OG0024 OG00311
Worsened	OG0000 OG0010 OG0020 OG0030

Title	Measurements
Improved	OG0000 OG0010 OG0020 OG0030
No change	OG0004 OG0013 OG0024 OG00311
Worsened	OG0000 OG0010 OG0020 OG0030

Title	Measurements
	OG000-2.60± 5.411 OG0011.25± 3.573 OG0020.93± 3.645 OG003-2.09± 3.198

Title	Measurements
	OG000-1.83± 4.664 OG0011.83± 1.756 OG0021.07± 2.901 OG003-1.43± 4.052

Title	Measurements
	OG000-2.73± 1.977 OG0012.23± 4.450 OG0021.45± 3.779 OG0030.60± 1.056

Title	Measurements
	OG000-0.38± 0.078 OG001-0.27± 0.222 OG002-0.25± 0.311 OG0030.03± 0.676

Title	Measurements
	OG000-0.39± 0.401 OG001-0.32± 0.495 OG002-0.19± 0.694 OG003-0.14± 0.736

Title	Measurements
	OG000-0.19± 0.388 OG001-0.12± 0.662 OG0020.24± 0.392 OG003-0.09± 0.710

Title	Measurements
	OG000-0.23± 0.301 OG001-0.01± 0.609 OG0020.10± 0.612 OG0030.35± 0.689

Title	Measurements
	OG000-0.05± 0.058 OG001-0.20± 0.201 OG002-0.07± 0.101 OG003-0.08± 0.507

Title	Measurements
	OG000-0.31± 0.403 OG0010.01± 0.340 OG002-0.15± 0.159 OG003-0.06± 0.504

Title	Measurements
	OG0000.03± 0.144 OG001-0.39± 0.460 OG002-0.09± 0.075 OG003-0.19± 0.451

Title	Measurements
	OG0000.36± 0.415 OG001-0.06± 0.191 OG0020.00± 0.084 OG003-0.07± 0.574