Cancer
Conditions
Brief summary
The study is intended as a Proof of Concept and dose confirmation study. The primary objective of this study is to observe safety and tolerability of idronoxil (NOX66) in combination with radiotherapy (at palliative doses) in patients with metastatic castrate-resistant prostate cancer (CRPC) and to confirm dose in order to progress to Phase 2/3.
Detailed description
This study will investigate three escalating doses of NOX66 in combination with palliative dose of radiation therapy to establish safety profile and / or obtain efficacy signals and to determine the optimal dose for future radiation therapy combination studies. The key hypotheses to be tested in this study are: 1. That NOX66 can be safely added to palliative dose radiation therapy. 2. That NOX66 may sensitise tumours to palliative doses of radiation therapy 3. That NOX66 in combination with radiation therapy may trigger or augment an abscopal effect Participants will have a minimum of 1 symptomatic lesion amenable to radiation therapy. Radiation therapy will be delivered at a 20Gy dosage over 5 fractions. NOX66 will be taken on 13 consecutive days starting 1 day prior to radiotherapy. The response of irradiated and non-irradiated target tumour lesions will be measured by CT/MRI scan and RECIST1.1 criteria at three time points post treatment. Pain response will be evaluated using the Brief Pain Inventory-Short Form (BPI-SF) instrument at five time points post treatment. Patients will be suitable for the study as they become indicated for palliative radiation therapy for management of their cancer. This study will enrol up to 24 patients in 3 NOX66 dose level cohorts of 4 patients (n=12) and an expansion cohort of 12 patients. Dose escalation decisions will be based on patients who experience adverse events directly related to NOX66 treatment. Following the review of accumulated safety data, disease status and treatment efficacy signals at WEEK 6 for the first 12 patients, the Study Steering Committee will determine the dose at which to continue treatment for the expansion patient Cohort 4 in the study. A further 12 patients will be recruited at this dose level.
Interventions
DRUGNOX66
NOX66 delivered as rectal suppository.
RADIATIONIrradiation Therapy
Radiation per selected tumour lesion.
Sponsors
Noxopharm Limited
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Provision of informed consent 2. ≥ 18 years of age 3. Histologically confirmed prostate cancer and/or PSA of \>100 ng/mL at original diagnosis 4. Metastatic disease evidenced by either CT/MRI imaging or bone scan 5. 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. 6. Eligible to receive palliative radiation therapy for management of disease 7. At least one symptomatic lesion which is suitable for radiation therapy 8. ECOG Performance status 0-2 9. A minimum life expectancy of 24 weeks 10. 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 11. Ongoing androgen deprivation therapy with luteinizing hormone-releasing hormone (LHRH) agonist or antagonist 12. 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. 13. At least 21 days must have elapsed following major surgery and any surgical incision should be completely healed.
Exclusion criteria
1. Tumour involvement of the central nervous system 2. Uncontrolled infection or systemic disease 3. 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 4. Concurrent systemic chemotherapy or biological therapy 5. Any situation where the use of suppository therapy is contra-indicated or impractical (eg. chronic diarrhoea, colostomy, ulcerative colitis). 6. Known human immunodeficiency virus (HIV) or Hepatitis B or C (active, previously treated or both) 7. Any subject whose testosterone is not suppressed i.e. is \> 0.5nmols/L 8. Any other reason which, in the opinion of the investigator, will preclude suitable participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events Including SAEs [Safety and Tolerability] of NOX66 Combined With Radiation Therapy at Multiple Timepoints | Day 2, Day 6, EOT (Day 16), Week 6, Week 12, and Week 24 | 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. |
| Assessment of Laboratory Results | From Baseline to End of Treatment (Day 16), Week 6, Week 12, and Week 24. | 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. |
| Assessment of ECG Results | Baseline to End of treatment (Day 16), Week 12, and Week 24. | Mean change from Baseline in ECG intervals (msec) which are assessed at End of treatment (Day 16), Week 12, and Week 24. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Overall Pain Score Using the Brief Pain Inventory - Short Form (BPI-SF) | From enrolment up to Day 16, Week 6, Week 12, and Week 24 | 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. |
| Change in Prostate Specific Antigen (PSA) Levels | From enrolment up to Week 6, Week 12, and Week 24 | Percentage change from baseline in serum PSA levels (ng/mL) at Week 6, Week 12, and Week 24 |
| Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 6, Week 12, and Week 24 | 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. |
| Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | From enrolment up to Day 2, End of Treatment (Day 16), Week 6, Week 12, and Week 24 | 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. |
| Change of ECOG Performance Status | From enrolment up to Week 6, Week 12, and Week 24 | Assessment of patient via ECOG Performance Status, which has a scale scored from 0 (Fully Active) to 5 (Dead). |
| Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria | Week 6, Week 12, and Week 24 | 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. |
| Overall Response According to RECIST 1.1 Criteria | From enrolment up to Week 6, Week 12, and Week 24 | 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) |
Countries
Australia, Georgia, New Zealand
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 4 |
| 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. | 6 |
| 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. | 4 |
| 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. | 11 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 0 | 3 | 0 | 1 |
| Overall Study | Disease Progression | 0 | 0 | 0 | 3 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 2 |
Baseline characteristics
| Characteristic | Cohort 1 - NOX66 400mg Daily | Total | Cohort 4 - NOX66 1200mg Daily | Cohort 3 - NOX66 1200mg Daily | Cohort 2 - NOX66 800mg Daily |
|---|---|---|---|---|---|
| Age, Continuous | 72.8 years STANDARD_DEVIATION 8.06 | 70.1 years STANDARD_DEVIATION 6.01 | 70.6 years STANDARD_DEVIATION 6.79 | 68.6 years STANDARD_DEVIATION 5.25 | 68.5 years STANDARD_DEVIATION 3.73 |
| Diagnostic PSA level | 560.00 ng/mL STANDARD_DEVIATION 579.828 | 321.92 ng/mL STANDARD_DEVIATION 258.95 | 154.0 ng/mL STANDARD_DEVIATION 101.402 | 488.7 ng/mL STANDARD_DEVIATION 0 | 222.38 ng/mL STANDARD_DEVIATION 123.755 |
| ECOG Performance Status at Screening 0 (Fully active) | 0 Participants | 4 Participants | 2 Participants | 2 Participants | 0 Participants |
| ECOG Performance Status at Screening 1 (Ambulatory; No strenuous activity) | 4 Participants | 21 Participants | 9 Participants | 2 Participants | 6 Participants |
| ECOG Performance Status at Screening 2 (Ambulatory; No work activity) | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| ECOG Performance Status at Screening 3 (Limited self-care) | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| ECOG Performance Status at Screening 4 (No self-care) | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| ECOG Performance Status at Screening 5 (Dead) | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 25 Participants | 11 Participants | 4 Participants | 6 Participants |
| Region of Enrollment Australia | 1 participants | 0 participants | 0 participants | 0 participants | 2 participants |
| Region of Enrollment Georgia | 3 participants | 0 participants | 11 participants | 3 participants | 4 participants |
| Region of Enrollment New Zealand | 0 participants | 0 participants | 0 participants | 1 participants | 0 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 4 Participants | 25 Participants | 11 Participants | 4 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 3 / 6 | 0 / 4 | 1 / 11 |
| other Total, other adverse events | 4 / 4 | 5 / 6 | 2 / 4 | 9 / 11 |
| serious Total, serious adverse events | 0 / 4 | 3 / 6 | 1 / 4 | 1 / 11 |
Outcome results
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.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 - NOX66 400mg Daily | Assessment of ECG Results | RR interval, Day 16 | 23.4 msec | Standard Deviation 50.15 |
| Cohort 1 - NOX66 400mg Daily | Assessment of ECG Results | QTc interval, Week 12 | 29.5 msec | Standard Deviation 30.88 |
| Cohort 1 - NOX66 400mg Daily | Assessment of ECG Results | RR interval, Week 12 | 35.1 msec | Standard Deviation 201.4 |
| Cohort 1 - NOX66 400mg Daily | Assessment of ECG Results | RR interval, Week 24 | -54.4 msec | Standard Deviation 82.71 |
| Cohort 1 - NOX66 400mg Daily | Assessment of ECG Results | QT interval, Day 16 | 24.1 msec | Standard Deviation 55.08 |
| Cohort 1 - NOX66 400mg Daily | Assessment of ECG Results | QT interval, Week 12 | 33.9 msec | Standard Deviation 68.59 |
| Cohort 1 - NOX66 400mg Daily | Assessment of ECG Results | QTc interval, Week 24 | 23.3 msec | Standard Deviation 29.57 |
| Cohort 1 - NOX66 400mg Daily | Assessment of ECG Results | QT interval, Week 24 | 9.7 msec | Standard Deviation 34.76 |
| Cohort 1 - NOX66 400mg Daily | Assessment of ECG Results | QTc interval, Day 16 | 19 msec | Standard Deviation 48.92 |
| Cohort 2 - NOX66 800mg Daily | Assessment of ECG Results | QTc interval, Day 16 | 19.7 msec | Standard Deviation 32.1 |
| Cohort 2 - NOX66 800mg Daily | Assessment of ECG Results | QT interval, Day 16 | -1.4 msec | Standard Deviation 33.29 |
| Cohort 2 - NOX66 800mg Daily | Assessment of ECG Results | QTc interval, Week 12 | 17.0 msec | Standard Deviation 24.99 |
| Cohort 2 - NOX66 800mg Daily | Assessment of ECG Results | QT interval, Week 12 | 4.8 msec | Standard Deviation 13.62 |
| Cohort 2 - NOX66 800mg Daily | Assessment of ECG Results | QT interval, Week 24 | 4.8 msec | Standard Deviation 27.69 |
| Cohort 2 - NOX66 800mg Daily | Assessment of ECG Results | RR interval, Day 16 | -56.4 msec | Standard Deviation 123.08 |
| Cohort 2 - NOX66 800mg Daily | Assessment of ECG Results | QTc interval, Week 24 | -2.6 msec | Standard Deviation 14.34 |
| Cohort 2 - NOX66 800mg Daily | Assessment of ECG Results | RR interval, Week 12 | -11.6 msec | Standard Deviation 150.02 |
| Cohort 2 - NOX66 800mg Daily | Assessment of ECG Results | RR interval, Week 24 | 31.8 msec | Standard Deviation 59.97 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of ECG Results | RR interval, Week 12 | -55.6 msec | Standard Deviation 140.05 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of ECG Results | RR interval, Week 24 | -17.2 msec | Standard Deviation 112.8 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of ECG Results | QT interval, Day 16 | 9 msec | Standard Deviation 22.16 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of ECG Results | RR interval, Day 16 | 7.6 msec | Standard Deviation 66.68 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of ECG Results | QTc interval, Day 16 | 11.1 msec | Standard Deviation 8.12 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of ECG Results | QT interval, Week 24 | 5.2 msec | Standard Deviation 25.62 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of ECG Results | QT interval, Week 12 | -7 msec | Standard Deviation 23.67 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of ECG Results | QTc interval, Week 12 | 12.7 msec | Standard Deviation 6.39 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of ECG Results | QTc interval, Week 24 | 6.1 msec | Standard Deviation 11.55 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of ECG Results | RR interval, Week 24 | 39.5 msec | Standard Deviation 38.78 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of ECG Results | RR interval, Week 12 | -20.1 msec | Standard Deviation 181.42 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of ECG Results | QT interval, Day 16 | 16.1 msec | Standard Deviation 33.53 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of ECG Results | QT interval, Week 12 | 7.6 msec | Standard Deviation 36.6 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of ECG Results | QT interval, Week 24 | 9.2 msec | Standard Deviation 12.55 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of ECG Results | QTc interval, Week 12 | 15 msec | Standard Deviation 25.5 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of ECG Results | QTc interval, Week 24 | 0.8 msec | Standard Deviation 16.61 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of ECG Results | RR interval, Day 16 | 4.5 msec | Standard Deviation 212.55 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of ECG Results | QTc interval, Day 16 | 17.9 msec | Standard Deviation 40.32 |
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.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Direct Bilirubin, Week 12 (micromol/L) | -0.12 micromol/L | Standard Deviation 0.872 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Creatinine, Week 6 (micromol/L) | 15.77 micromol/L | Standard Deviation 45.051 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Total Bilirubin, Day 16 (micromol/L) | 1.85 micromol/L | Standard Deviation 2.229 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Direct Bilirubin, Week 24 (micromol/L) | -0.03 micromol/L | Standard Deviation 0.227 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Direct Bilirubin, Day 16 (micromol/L) | 0.33 micromol/L | Standard Deviation 0.583 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Creatinine, Week 24 (micromol/L) | -5.98 micromol/L | Standard Deviation 17.68 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Creatinine, Day 16 (micromol/L) | 7.84 micromol/L | Standard Deviation 38.883 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Total Bilirubin, Week 24 (micromol/L) | -1.35 micromol/L | Standard Deviation 2.928 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Direct Bilirubin, Week 6 (micromol/L) | 0.33 micromol/L | Standard Deviation 0.481 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Creatinine, Week 12 (micromol/L) | -4.93 micromol/L | Standard Deviation 11.097 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Total Bilirubin, Week 12 (micromol/L) | -1.12 micromol/L | Standard Deviation 3.749 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Total Bilirubin, Week 6 (micromol/L) | 2.45 micromol/L | Standard Deviation 1.937 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Total Bilirubin, Week 6 (micromol/L) | 0.59 micromol/L | Standard Deviation 0.897 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Direct Bilirubin, Day 16 (micromol/L) | -0.78 micromol/L | Standard Deviation 1.487 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Direct Bilirubin, Week 6 (micromol/L) | -0.68 micromol/L | Standard Deviation 0.864 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Direct Bilirubin, Week 12 (micromol/L) | -0.46 micromol/L | Standard Deviation 0.173 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Direct Bilirubin, Week 24 (micromol/L) | -0.70 micromol/L | Standard Deviation 0.735 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Total Bilirubin, Day 16 (micromol/L) | -0.35 micromol/L | Standard Deviation 3.488 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Total Bilirubin, Week 12 (micromol/L) | 0.90 micromol/L | Standard Deviation 1.137 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Total Bilirubin, Week 24 (micromol/L) | -0.30 micromol/L | Standard Deviation 0.567 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Creatinine, Day 16 (micromol/L) | 4.64 micromol/L | Standard Deviation 8.619 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Creatinine, Week 6 (micromol/L) | -5.51 micromol/L | Standard Deviation 9.603 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Creatinine, Week 12 (micromol/L) | 16.32 micromol/L | Standard Deviation 43.026 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Creatinine, Week 24 (micromol/L) | -5.36 micromol/L | Standard Deviation 9.032 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Creatinine, Day 16 (micromol/L) | 5.87 micromol/L | Standard Deviation 8.122 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Direct Bilirubin, Week 6 (micromol/L) | -0.26 micromol/L | Standard Deviation 0.497 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Creatinine, Week 12 (micromol/L) | -10.70 micromol/L | Standard Deviation 0.3 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Creatinine, Week 24 (micromol/L) | -8.90 micromol/L | Standard Deviation 4.845 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Total Bilirubin, Week 24 (micromol/L) | -1.43 micromol/L | Standard Deviation 3.404 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Creatinine, Week 6 (micromol/L) | -2.33 micromol/L | Standard Deviation 3.121 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Direct Bilirubin, Week 24 (micromol/L) | -0.26 micromol/L | Standard Deviation 0.549 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Total Bilirubin, Week 12 (micromol/L) | 1.46 micromol/L | Standard Deviation 2.034 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Direct Bilirubin, Week 12 (micromol/L) | -0.39 micromol/L | Standard Deviation 0.521 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Direct Bilirubin, Day 16 (micromol/L) | -0.08 micromol/L | Standard Deviation 0.415 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Total Bilirubin, Day 16 (micromol/L) | -0.63 micromol/L | Standard Deviation 2.447 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Total Bilirubin, Week 6 (micromol/L) | -0.48 micromol/L | Standard Deviation 1.754 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Total Bilirubin, Day 16 (micromol/L) | -0.26 micromol/L | Standard Deviation 0.831 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Total Bilirubin, Week 6 (micromol/L) | -0.76 micromol/L | Standard Deviation 1.12 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Total Bilirubin, Week 12 (micromol/L) | -0.92 micromol/L | Standard Deviation 1.915 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Direct Bilirubin, Day 16 (micromol/L) | 0.16 micromol/L | Standard Deviation 0.494 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Total Bilirubin, Week 24 (micromol/L) | -1.28 micromol/L | Standard Deviation 2.483 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Creatinine, Day 16 (micromol/L) | -2.90 micromol/L | Standard Deviation 8.787 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Creatinine, Week 12 (micromol/L) | -10.63 micromol/L | Standard Deviation 20.908 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Creatinine, Week 24 (micromol/L) | -13.39 micromol/L | Standard Deviation 16.696 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Direct Bilirubin, Week 12 (micromol/L) | 0.19 micromol/L | Standard Deviation 0.929 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Direct Bilirubin, Week 24 (micromol/L) | 0.05 micromol/L | Standard Deviation 0.135 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Creatinine, Week 6 (micromol/L) | 12.89 micromol/L | Standard Deviation 21.919 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Direct Bilirubin, Week 6 (micromol/L) | -0.09 micromol/L | Standard Deviation 0.32 |
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.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Calcium, Week 6 (mmol/L) | -0.31 mmol/L | Standard Deviation 0.403 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Calcium, Week 24 (mmol/L) | 0.36 mmol/L | Standard Deviation 0.415 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Potassium, Week 24 (mmol/L) | -0.23 mmol/L | Standard Deviation 0.301 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Sodium, Day 16 (mmol/L) | -2.10 mmol/L | Standard Deviation 3.075 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Calcium, Day 16 (mmol/L) | -0.05 mmol/L | Standard Deviation 0.058 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Sodium, Week 12 (mmol/L) | -1.83 mmol/L | Standard Deviation 4.664 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Sodium, Week 24 (mmol/L) | -2.73 mmol/L | Standard Deviation 1.977 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Sodium, Week 6 (mmol/L) | -2.60 mmol/L | Standard Deviation 5.411 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Calcium, Week 12 (mmol/L) | 0.03 mmol/L | Standard Deviation 0.144 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Potassium, Day 16 (mmol/L) | -0.38 mmol/L | Standard Deviation 0.078 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Potassium, Week 6 (mmol/L) | -0.39 mmol/L | Standard Deviation 0.401 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Potassium, Week 12 (mmol/L) | -0.19 mmol/L | Standard Deviation 0.388 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Sodium, Week 6 (mmol/L) | 1.25 mmol/L | Standard Deviation 3.573 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Potassium, Week 12 (mmol/L) | -0.12 mmol/L | Standard Deviation 0.662 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Sodium, Week 24 (mmol/L) | 2.23 mmol/L | Standard Deviation 4.45 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Calcium, Day 16 (mmol/L) | -0.20 mmol/L | Standard Deviation 0.201 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Calcium, Week 6 (mmol/L) | 0.01 mmol/L | Standard Deviation 0.34 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Potassium, Week 24 (mmol/L) | -0.01 mmol/L | Standard Deviation 0.609 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Sodium, Day 16 (mmol/L) | -0.65 mmol/L | Standard Deviation 2.62 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Potassium, Week 6 (mmol/L) | -0.32 mmol/L | Standard Deviation 0.495 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Potassium, Day 16 (mmol/L) | -0.27 mmol/L | Standard Deviation 0.222 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Sodium, Week 12 (mmol/L) | 1.83 mmol/L | Standard Deviation 1.756 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Calcium, Week 24 (mmol/L) | -0.06 mmol/L | Standard Deviation 0.191 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Calcium, Week 12 (mmol/L) | -0.39 mmol/L | Standard Deviation 0.46 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Potassium, Week 24 (mmol/L) | 0.10 mmol/L | Standard Deviation 0.612 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Sodium, Day 16 (mmol/L) | -0.180 mmol/L | Standard Deviation 2.917 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Sodium, Week 6 (mmol/L) | 0.93 mmol/L | Standard Deviation 3.645 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Sodium, Week 12 (mmol/L) | 1.07 mmol/L | Standard Deviation 2.901 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Sodium, Week 24 (mmol/L) | 1.45 mmol/L | Standard Deviation 3.779 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Potassium, Day 16 (mmol/L) | -0.25 mmol/L | Standard Deviation 0.311 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Potassium, Week 6 (mmol/L) | -0.19 mmol/L | Standard Deviation 0.694 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Potassium, Week 12 (mmol/L) | 0.24 mmol/L | Standard Deviation 0.392 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Calcium, Day 16 (mmol/L) | -0.07 mmol/L | Standard Deviation 0.101 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Calcium, Week 6 (mmol/L) | -0.15 mmol/L | Standard Deviation 0.159 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Calcium, Week 12 (mmol/L) | -0.09 mmol/L | Standard Deviation 0.075 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Calcium, Week 24 (mmol/L) | 0.00 mmol/L | Standard Deviation 0.084 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Potassium, Week 6 (mmol/L) | -0.14 mmol/L | Standard Deviation 0.736 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Potassium, Day 16 (mmol/L) | 0.03 mmol/L | Standard Deviation 0.676 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Sodium, Day 16 (mmol/L) | -1.52 mmol/L | Standard Deviation 3.257 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Calcium, Week 6 (mmol/L) | -0.06 mmol/L | Standard Deviation 0.504 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Sodium, Week 24 (mmol/L) | 0.60 mmol/L | Standard Deviation 1.056 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Sodium, Week 12 (mmol/L) | -1.43 mmol/L | Standard Deviation 4.052 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Calcium, Week 24 (mmol/L) | -0.07 mmol/L | Standard Deviation 0.574 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Calcium, Week 12 (mmol/L) | -0.19 mmol/L | Standard Deviation 0.451 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Potassium, Week 24 (mmol/L) | 0.35 mmol/L | Standard Deviation 0.689 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Potassium, Week 12 (mmol/L) | -0.09 mmol/L | Standard Deviation 0.71 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Sodium, Week 6 (mmol/L) | -2.09 mmol/L | Standard Deviation 3.198 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Calcium, Day 16 (mmol/L) | -0.08 mmol/L | Standard Deviation 0.507 |
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.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Basophils, Week 6 (10^9/L) | 0.30 10^9cells/L | Standard Deviation 0.632 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Monocytes, Week 24 (10^9/L) | -0.42 10^9cells/L | Standard Deviation 0.565 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Lymphocytes, Week 24 (10^9/L) | -0.45 10^9cells/L | Standard Deviation 0.768 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Neutrophils, Day 16 (10^9/L) | -0.02 10^9cells/L | Standard Deviation 1.396 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Neutrophils, Week 6 (10^9/L) | -2.27 10^9cells/L | Standard Deviation 0.641 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Basophils, Week 12 (10^9/L) | 0.00 10^9cells/L | Standard Deviation 0.005 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Monocytes, Week 12 (10^9/L) | -0.55 10^9cells/L | Standard Deviation 0.629 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Neutrophils, Week 12 (10^9/L) | -2.00 10^9cells/L | Standard Deviation 1.956 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Neutrophils, Week 24 (10^9/L) | -1.50 10^9cells/L | Standard Deviation 0.776 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Monocytes, Week 6 (10^9/L) | -0.42 10^9cells/L | Standard Deviation 622 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Platelets, Day 16 (10^9/L) | -66.50 10^9cells/L | Standard Deviation 50.849 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Lymphocytes, Week 12 (10^9/L) | -0.38 10^9cells/L | Standard Deviation 0.682 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Basophils, Day 16 (10^9/L) | -0.01 10^9cells/L | Standard Deviation 0.01 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Platelets, Week 6 (10^9/L) | -81.50 10^9cells/L | Standard Deviation 49.143 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Platelets, Week 12 (10^9/L) | -60.0 10^9cells/L | Standard Deviation 101.278 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Basophils, Week 24 (10^9/L) | -0.01 10^9cells/L | Standard Deviation 0.033 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Eosinophils, Week 24 (10^9/L) | -0.02 10^9cells/L | Standard Deviation 0.042 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | White Blood Cells, Day 16 (10^9/L) | -2.99 10^9cells/L | Standard Deviation 1.536 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Monocytes, Day 16 (10^9/L) | -0.39 10^9cells/L | Standard Deviation 0.623 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | White Blood Cells, Week 6 (10^9/L) | -3.13 10^9cells/L | Standard Deviation 0.884 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Eosinophils, Week 6 (10^9/L) | 0.01 10^9cells/L | Standard Deviation 0.059 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | White Blood Cells, Week 12 (10^9/L) | -2.93 10^9cells/L | Standard Deviation 2.24 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Platelets, Week 24 (10^9/L) | 86.75 10^9cells/L | Standard Deviation 54.872 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | White Blood Cells, Week 24 (10^9/L) | -2.42 10^9cells/L | Standard Deviation 1.754 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Eosinophils, Week 12 (10^9/L) | 0.00 10^9cells/L | Standard Deviation 0.081 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Eosinophils, Day 16 (10^9/L) | 0.00 10^9cells/L | Standard Deviation 0.081 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Lymphocytes, Day 16 (10^9/L) | -0.57 10^9cells/L | Standard Deviation 0.675 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Lymphocytes, Week 6 (10^9/L) | 0.44 10^9cells/L | Standard Deviation 0.497 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Platelets, Week 12 (10^9/L) | 36.25 10^9cells/L | Standard Deviation 182.967 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Basophils, Day 16 (10^9/L) | -0.01 10^9cells/L | Standard Deviation 0.02 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Basophils, Week 12 (10^9/L) | 0.03 10^9cells/L | Standard Deviation 0.066 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Eosinophils, Week 24 (10^9/L) | -0.09 10^9cells/L | Standard Deviation 0.148 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Lymphocytes, Week 24 (10^9/L) | -1.25 10^9cells/L | Standard Deviation 0.67 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Lymphocytes, Day 16 (10^9/L) | -0.41 10^9cells/L | Standard Deviation 0.77 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Monocytes, Week 12 (10^9/L) | 0.02 10^9cells/L | Standard Deviation 0.31 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Platelets, Week 24 (10^9/L) | -74.00 10^9cells/L | Standard Deviation 65.818 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | White Blood Cells, Week 12 (10^9/L) | 0.69 10^9cells/L | Standard Deviation 2.565 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Neutrophils, Week 6 (10^9/L) | -0.77 10^9cells/L | Standard Deviation 0.78 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Lymphocytes, Week 6 (10^9/L) | -0.75 10^9cells/L | Standard Deviation 0.838 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Eosinophils, Day 16 (10^9/L) | 0.02 10^9cells/L | Standard Deviation 122 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | White Blood Cells, Day 16 (10^9/L) | 1.20 10^9cells/L | Standard Deviation 1.694 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Neutrophils, Week 12 (10^9/L) | 0.83 10^9cells/L | Standard Deviation 1.466 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Lymphocytes, Week 12 (10^9/L) | -0.29 10^9cells/L | Standard Deviation 0.792 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Monocytes, Week 6 (10^9/L) | -0.13 10^9cells/L | Standard Deviation 0.108 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Eosinophils, Week 12 (10^9/L) | 0.04 10^9cells/L | Standard Deviation 0.333 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Neutrophils, Week 24 (10^9/L) | 0.11 10^9cells/L | Standard Deviation 0.896 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Basophils, Week 6 (10^9/L) | -0.01 10^9cells/L | Standard Deviation 0.01 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Eosinophils, Week 6 (10^9/L) | 0.06 10^9cells/L | Standard Deviation 0.12 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Basophils, Week 24 (10^9/L) | -0.02 10^9cells/L | Standard Deviation 0.006 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | White Blood Cells, Week 24 (10^9/L) | -1.37 10^9cells/L | Standard Deviation 1.086 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Platelets, Day 16 (10^9/L) | -37.00 10^9cells/L | Standard Deviation 135.89 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | White Blood Cells, Week 6 (10^9/L) | -1.60 10^9cells/L | Standard Deviation 1.632 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Monocytes, Day 16 (10^9/L) | 0.19 10^9cells/L | Standard Deviation 0.13 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Monocytes, Week 24 (10^9/L) | -0.11 10^9cells/L | Standard Deviation 0.21 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Platelets, Week 6 (10^9/L) | -60.50 10^9cells/L | Standard Deviation 86.002 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Neutrophils, Day 16 (10^9/L) | 1.38 10^9cells/L | Standard Deviation 1.926 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Eosinophils, Week 12 (10^9/L) | -0.02 10^9cells/L | Standard Deviation 0.076 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Neutrophils, Day 16 (10^9/L) | 1.47 10^9cells/L | Standard Deviation 1.683 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Monocytes, Day 16 (10^9/L) | 0.25 10^9cells/L | Standard Deviation 0.2 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Basophils, Day 16 (10^9/L) | 0.00 10^9cells/L | Standard Deviation 0.006 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Basophils, Week 6 (10^9/L) | 0.02 10^9cells/L | Standard Deviation 0.029 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Platelets, Day 16 (10^9/L) | -9.00 10^9cells/L | Standard Deviation 121.351 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Platelets, Week 6 (10^9/L) | 83.00 10^9cells/L | Standard Deviation 95.781 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Platelets, Week 12 (10^9/L) | -8.33 10^9cells/L | Standard Deviation 129.894 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Platelets, Week 24 (10^9/L) | 34.75 10^9cells/L | Standard Deviation 141.354 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | White Blood Cells, Day 16 (10^9/L) | 2.10 10^9cells/L | Standard Deviation 2.217 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | White Blood Cells, Week 6 (10^9/L) | 3.42 10^9cells/L | Standard Deviation 2.217 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | White Blood Cells, Week 12 (10^9/L) | 4.62 10^9cells/L | Standard Deviation 3.975 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | White Blood Cells, Week 24 (10^9/L) | 2.63 10^9cells/L | Standard Deviation 3.498 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Lymphocytes, Day 16 (10^9/L) | 0.35 10^9cells/L | Standard Deviation 0.71 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Lymphocytes, Week 6 (10^9/L) | 0.46 10^9cells/L | Standard Deviation 0.901 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Lymphocytes, Week 12 (10^9/L) | 0.24 10^9cells/L | Standard Deviation 1.279 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Lymphocytes, Week 24 (10^9/L) | 0.05 10^9cells/L | Standard Deviation 0.854 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Neutrophils, Week 6 (10^9/L) | 2.76 10^9cells/L | Standard Deviation 1.05 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Neutrophils, Week 12 (10^9/L) | 4.27 10^9cells/L | Standard Deviation 3.309 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Neutrophils, Week 24 (10^9/L) | 2.47 10^9cells/L | Standard Deviation 2.607 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Monocytes, Week 6 (10^9/L) | 0.15 10^9cells/L | Standard Deviation 0.137 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Monocytes, Week 12 (10^9/L) | 0.12 10^9cells/L | Standard Deviation 0.827 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Monocytes, Week 24 (10^9/L) | 0.13 10^9cells/L | Standard Deviation 0.541 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Eosinophils, Day 16 (10^9/L) | 0.05 10^9cells/L | Standard Deviation 0.097 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Eosinophils, Week 6 (10^9/L) | 0.04 10^9cells/L | Standard Deviation 0.162 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Eosinophils, Week 24 (10^9/L) | 0.00 10^9cells/L | Standard Deviation 0.105 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Basophils, Week 12 (10^9/L) | 0.00 10^9cells/L | Standard Deviation 0.006 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Basophils, Week 24 (10^9/L) | 0.00 10^9cells/L | Standard Deviation 0 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Monocytes, Week 12 (10^9/L) | 0.05 10^9cells/L | Standard Deviation 0.396 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Lymphocytes, Week 12 (10^9/L) | -0.34 10^9cells/L | Standard Deviation 1.175 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Lymphocytes, Day 16 (10^9/L) | -0.66 10^9cells/L | Standard Deviation 1.113 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Basophils, Week 24 (10^9/L) | -0.01 10^9cells/L | Standard Deviation 0.02 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Monocytes, Week 24 (10^9/L) | 0.29 10^9cells/L | Standard Deviation 0.473 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | White Blood Cells, Week 24 (10^9/L) | -2.23 10^9cells/L | Standard Deviation 2.676 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | White Blood Cells, Week 12 (10^9/L) | -1.02 10^9cells/L | Standard Deviation 2.331 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Basophils, Week 12 (10^9/L) | 0.00 10^9cells/L | Standard Deviation 0.013 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Eosinophils, Day 16 (10^9/L) | 0.05 10^9cells/L | Standard Deviation 0.293 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | White Blood Cells, Week 6 (10^9/L) | -1.55 10^9cells/L | Standard Deviation 1.543 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | White Blood Cells, Day 16 (10^9/L) | -2.23 10^9cells/L | Standard Deviation 2.269 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Neutrophils, Day 16 (10^9/L) | -1.85 10^9cells/L | Standard Deviation 1.926 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Eosinophils, Week 6 (10^9/L) | -0.06 10^9cells/L | Standard Deviation 0.176 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Eosinophils, Week 12 (10^9/L) | -0.07 10^9cells/L | Standard Deviation 0.09 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Platelets, Week 24 (10^9/L) | 0.20 10^9cells/L | Standard Deviation 79.998 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Platelets, Week 12 (10^9/L) | 28.36 10^9cells/L | Standard Deviation 73.595 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Lymphocytes, Week 6 (10^9/L) | -0.39 10^9cells/L | Standard Deviation 1.238 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Eosinophils, Week 24 (10^9/L) | -0.06 10^9cells/L | Standard Deviation 0.119 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Platelets, Day 16 (10^9/L) | -45.45 10^9cells/L | Standard Deviation 104.516 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Basophils, Week 6 (10^9/L) | 0.01 10^9cells/L | Standard Deviation 0.019 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Monocytes, Day 16 (10^9/L) | -0.06 10^9cells/L | Standard Deviation 0.315 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Neutrophils, Week 24 (10^9/L) | -2.33 10^9cells/L | Standard Deviation 2.571 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Neutrophils, Week 12 (10^9/L) | -1.03 10^9cells/L | Standard Deviation 2.245 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Basophils, Day 16 (10^9/L) | 0.00 10^9cells/L | Standard Deviation 0.023 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Monocytes, Week 6 (10^9/L) | -0.05 10^9cells/L | Standard Deviation 0.359 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Neutrophils, Week 6 (10^9/L) | -1.50 10^9cells/L | Standard Deviation 1.906 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Lymphocytes, Week 24 (10^9/L) | -0.71 10^9cells/L | Standard Deviation 1.761 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Platelets, Week 6 (10^9/L) | -17.09 10^9cells/L | Standard Deviation 58.066 |
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.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Haemoglobin, Week 24 (g/L) | 3.50 (g/L | Standard Deviation 6.608 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Total Protein, Week 12 (g/L) | 3.63 (g/L | Standard Deviation 5.397 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Mean Corpuscular Haemoglobin Concentration, Day 16 (g/L) | -16.75 (g/L | Standard Deviation 34.267 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Total Protein, Week 6 (g/L) | 4.04 (g/L | Standard Deviation 10.15 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Mean Corpuscular Haemoglobin Concentration, Week 6 (g/L) | 16.75 (g/L | Standard Deviation 38.922 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Total Protein, Day 16 (g/L) | 4.52 (g/L | Standard Deviation 6.7 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Albumin, Week 24 (g/L) | -0.78 (g/L | Standard Deviation 3.497 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Haemoglobin, Day 16 (g/L) | -0.5 (g/L | Standard Deviation 5.066 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Albumin, Week 12 (g/L) | 0.10 (g/L | Standard Deviation 2.761 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Albumin, Week 6 (g/L) | -1.68 (g/L | Standard Deviation 2.538 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Albumin, Day 16 (g/L) | 0.80 (g/L | Standard Deviation 7.532 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Haemoglobin, Week 6 (g/L) | -7.25 (g/L | Standard Deviation 13.598 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Total Protein, Week 24 (g/L) | 1.43 (g/L | Standard Deviation 4.742 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Haemoglobin, Week 12 (g/L) | 11.00 (g/L | Standard Deviation 14.855 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Mean Corpuscular Haemoglobin Concentration, Week 24 (g/L) | -5.5 (g/L | Standard Deviation 31.754 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Mean Corpuscular Haemoglobin Concentration, Week 12 (g/L) | -13.00 (g/L | Standard Deviation 29.178 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Haemoglobin, Day 16 (g/L) | -6.17 (g/L | Standard Deviation 9.579 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Haemoglobin, Week 6 (g/L) | -8.50 (g/L | Standard Deviation 17.54 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Haemoglobin, Week 12 (g/L) | 4.75 (g/L | Standard Deviation 21.14 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Haemoglobin, Week 24 (g/L) | -2.00 (g/L | Standard Deviation 21.932 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Mean Corpuscular Haemoglobin Concentration, Day 16 (g/L) | -2.40 (g/L | Standard Deviation 8.989 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Mean Corpuscular Haemoglobin Concentration, Week 6 (g/L) | -4.25 (g/L | Standard Deviation 11.325 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Mean Corpuscular Haemoglobin Concentration, Week 12 (g/L) | -6.00 (g/L | Standard Deviation 8.888 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Mean Corpuscular Haemoglobin Concentration, Week 24 (g/L) | -2.67 (g/L | Standard Deviation 6.506 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Albumin, Day 16 (g/L) | -1.88 (g/L | Standard Deviation 5.518 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Albumin, Week 6 (g/L) | 4.58 (g/L | Standard Deviation 8.423 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Albumin, Week 12 (g/L) | 3.77 (g/L | Standard Deviation 8.07 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Albumin, Week 24 (g/L) | 3.77 (g/L | Standard Deviation 8.07 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Total Protein, Day 16 (g/L) | 0.36 (g/L | Standard Deviation 7.813 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Total Protein, Week 6 (g/L) | 5.36 (g/L | Standard Deviation 7.813 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Total Protein, Week 12 (g/L) | 7.44 (g/L | Standard Deviation 12.707 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Total Protein, Week 24 (g/L) | 5.15 (g/L | Standard Deviation 14.853 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Mean Corpuscular Haemoglobin Concentration, Day 16 (g/L) | -4.33 (g/L | Standard Deviation 12.662 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Albumin, Day 16 (g/L) | 0.34 (g/L | Standard Deviation 4.418 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Total Protein, Day 16 (g/L) | -0.08 (g/L | Standard Deviation 7.023 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Haemoglobin, Week 6 (g/L) | -4.75 (g/L | Standard Deviation 10.532 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Total Protein, Week 12 (g/L) | 0.27 (g/L | Standard Deviation 15.883 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Albumin, Week 12 (g/L) | -1.01 (g/L | Standard Deviation 9.782 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Mean Corpuscular Haemoglobin Concentration, Week 6 (g/L) | 1.67 (g/L | Standard Deviation 2.082 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Haemoglobin, Week 24 (g/L) | -4.25 (g/L | Standard Deviation 6.397 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Haemoglobin, Day 16 (g/L) | 1.5 (g/L | Standard Deviation 10.083 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Total Protein, Week 6 (g/L) | -0.08 (g/L | Standard Deviation 7.023 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Mean Corpuscular Haemoglobin Concentration, Week 12 (g/L) | -1.33 (g/L | Standard Deviation 12.702 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Total Protein, Week 24 (g/L) | -2.68 (g/L | Standard Deviation 13.654 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Haemoglobin, Week 12 (g/L) | -6.00 (g/L | Standard Deviation 6.083 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Albumin, Week 24 (g/L) | -2.60 (g/L | Standard Deviation 8.497 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Mean Corpuscular Haemoglobin Concentration, Week 24 (g/L) | -2.67 (g/L | Standard Deviation 8.622 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Albumin, Week 6 (g/L) | -0.66 (g/L | Standard Deviation 7.579 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Mean Corpuscular Haemoglobin Concentration, Week 24 (g/L) | -0.80 (g/L | Standard Deviation 11.756 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Albumin, Day 16 (g/L) | -0.63 (g/L | Standard Deviation 4.785 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Albumin, Week 6 (g/L) | -3.88 (g/L | Standard Deviation 7.482 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Albumin, Week 12 (g/L) | -1.84 (g/L | Standard Deviation 5.678 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Mean Corpuscular Haemoglobin Concentration, Day 16 (g/L) | 0.73 (g/L | Standard Deviation 3.062 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Total Protein, Week 12 (g/L) | -0.68 (g/L | Standard Deviation 6.808 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Albumin, Week 24 (g/L) | 0.58 (g/L | Standard Deviation 5.053 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Haemoglobin, Week 6 (g/L) | -11.27 (g/L | Standard Deviation 8.81 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Total Protein, Day 16 (g/L) | 0.23 (g/L | Standard Deviation 5.626 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Haemoglobin, Week 24 (g/L) | -14.60 (g/L | Standard Deviation 23.341 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Total Protein, Week 24 (g/L) | 0.15 (g/L | Standard Deviation 6.919 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Mean Corpuscular Haemoglobin Concentration, Week 6 (g/L) | -2.00 (g/L | Standard Deviation 9.96 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Haemoglobin, Week 12 (g/L) | -7.45 (g/L | Standard Deviation 15.247 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Mean Corpuscular Haemoglobin Concentration, Week 12 (g/L) | -8.09 (g/L | Standard Deviation 28.339 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Total Protein, Week 6 (g/L) | -2.59 (g/L | Standard Deviation 9.247 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Haemoglobin, Day 16 (g/L) | -11.27 (g/L | Standard Deviation 8.956 |
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.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Red Blood Cells, Day 16 (10^12/L) | 0.05 10^12cells/L | Standard Deviation 0.155 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Red Blood Cells, Week 6 (10^12/L) | -0.11 10^12cells/L | Standard Deviation 0.415 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Red Blood Cells, Week 12 (10^12/L) | 0.55 10^12cells/L | Standard Deviation 0.631 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Red Blood Cells, Week 24 (10^12/L) | 0.09 10^12cells/L | Standard Deviation 0.567 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Red Blood Cells, Week 6 (10^12/L) | -0.34 10^12cells/L | Standard Deviation 0.651 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Red Blood Cells, Week 12 (10^12/L) | 0.18 10^12cells/L | Standard Deviation 0.7856 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Red Blood Cells, Week 24 (10^12/L) | -0.13 10^12cells/L | Standard Deviation 0.766 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Red Blood Cells, Day 16 (10^12/L) | -0.09 10^12cells/L | Standard Deviation 0.526 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Red Blood Cells, Week 12 (10^12/L) | -0.31 10^12cells/L | Standard Deviation 0.176 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Red Blood Cells, Week 6 (10^12/L) | -0.18 10^12cells/L | Standard Deviation 0.599 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Red Blood Cells, Week 24 (10^12/L) | -0.28 10^12cells/L | Standard Deviation 0.35 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Red Blood Cells, Day 16 (10^12/L) | 0.25 10^12cells/L | Standard Deviation 0.454 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Red Blood Cells, Week 24 (10^12/L) | -0.32 10^12cells/L | Standard Deviation 0.887 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Red Blood Cells, Week 6 (10^12/L) | -0.32 10^12cells/L | Standard Deviation 0.59 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Red Blood Cells, Day 16 (10^12/L) | -0.37 10^12cells/L | Standard Deviation 0.445 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Red Blood Cells, Week 12 (10^12/L) | 0.01 10^12cells/L | Standard Deviation 0.997 |
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.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | AST, Week 6 (U/L) | 5.24 U/L | Standard Deviation 6.508 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | ALP, Week 24 (U/L) | 271.30 U/L | Standard Deviation 172.254 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | ALT, Week 24 (U/L) | -0.96 U/L | Standard Deviation 1.077 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | AST, Week 12 (U/L) | 2.14 U/L | Standard Deviation 1.919 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | ALT, Day 16 (U/L) | 0.56 U/L | Standard Deviation 2.38 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | ALP, Week 6 (U/L) | 228.28 U/L | Standard Deviation 230.132 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | AST, Day 16 (U/L) | 2.14 U/L | Standard Deviation 0.869 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | ALP, Week 12 (U/L) | 261.98 U/L | Standard Deviation 220.518 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | ALT, Week 12 (U/L) | 0.40 U/L | Standard Deviation 2.637 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | ALP, Day 16 (U/L) | 57.53 U/L | Standard Deviation 83.556 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | ALT, Week 6 (U/L) | 0.93 U/L | Standard Deviation 3.621 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | AST, Week 24 (U/L) | 6.64 U/L | Standard Deviation 6.137 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | ALT, Week 6 (U/L) | -1.24 U/L | Standard Deviation 4.199 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | AST, Week 12 (U/L) | -1.26 U/L | Standard Deviation 5.592 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | AST, Week 6 (U/L) | 0.74 U/L | Standard Deviation 2.413 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | ALP, Week 24 (U/L) | -167.33 U/L | Standard Deviation 328.804 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | AST, Week 24 (U/L) | -3.42 U/L | Standard Deviation 8.199 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | ALT, Week 12 (U/L) | -5.93 U/L | Standard Deviation 15.796 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | ALP, Week 12 (U/L) | -142.00 U/L | Standard Deviation 225.295 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | ALP, Week 6 (U/L) | -95.55 U/L | Standard Deviation 193.289 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | ALT, Week 24 (U/L) | 0.56 U/L | Standard Deviation 4.801 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | AST, Day 16 (U/L) | 5.87 U/L | Standard Deviation 6.867 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | ALP, Day 16 (U/L) | -35.34 U/L | Standard Deviation 142460 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | ALT, Day 16 (U/L) | 0.02 U/L | Standard Deviation 13.231 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | ALP, Week 12 (U/L) | -17.00 U/L | Standard Deviation 7.791 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | ALP, Week 24 (U/L) | -16.10 U/L | Standard Deviation 12.928 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | ALT, Day 16 (U/L) | 0.13 U/L | Standard Deviation 2.347 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | ALT, Week 6 (U/L) | -0.28 U/L | Standard Deviation 6.779 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | ALT, Week 12 (U/L) | -1.80 U/L | Standard Deviation 6.948 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | ALT, Week 24 (U/L) | -0.85 U/L | Standard Deviation 2.42 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | AST, Day 16 (U/L) | 0.00 U/L | Standard Deviation 0 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | AST, Week 6 (U/L) | 1.08 U/L | Standard Deviation 2.045 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | AST, Week 24 (U/L) | -0.78 U/L | Standard Deviation 2.382 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | AST, Week 12 (U/L) | 4.03 U/L | Standard Deviation 1.861 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | ALP, Day 16 (U/L) | -11.53 U/L | Standard Deviation 13.814 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | ALP, Week 6 (U/L) | 3.60 U/L | Standard Deviation 31.794 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | AST, Week 24 (U/L) | -2.08 U/L | Standard Deviation 3.281 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | ALT, Day 16 (U/L) | -0.65 U/L | Standard Deviation 8.07 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | AST, Week 6 (U/L) | -4.87 U/L | Standard Deviation 6.7 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | ALP, Week 24 (U/L) | -26.66 U/L | Standard Deviation 27.916 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | ALP, Day 16 (U/L) | -33.68 U/L | Standard Deviation 176.815 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | ALT, Week 24 (U/L) | -1.11 U/L | Standard Deviation 2.961 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | ALT, Week 12 (U/L) | -4.58 U/L | Standard Deviation 11.113 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | ALP, Week 12 (U/L) | 144.01 U/L | Standard Deviation 250.644 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | ALP, Week 6 (U/L) | -11.73 U/L | Standard Deviation 184.158 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | AST, Day 16 (U/L) | -4.59 U/L | Standard Deviation 9.102 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | ALT, Week 6 (U/L) | 0.00 U/L | Standard Deviation 8.286 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | AST, Week 12 (U/L) | 5.03 U/L | Standard Deviation 23.916 |
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.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Mean Corpuscular Volume, Day 16 (fL) | 4.10 fL | Standard Deviation 6.968 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Mean Corpuscular Volume, Week 6 (fL) | 4.60 fL | Standard Deviation 7.124 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Mean Corpuscular Volume, Week 12 (fL) | 3.50 fL | Standard Deviation 3.696 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Mean Corpuscular Volume, Week 24 (fL) | 5.05 fL | Standard Deviation 6.357 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Mean Corpuscular Volume, Week 6 (fL) | 2.40 fL | Standard Deviation 3.713 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Mean Corpuscular Volume, Week 12 (fL) | 1.10 fL | Standard Deviation 3.451 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Mean Corpuscular Volume, Week 24 (fL) | 2.03 fL | Standard Deviation 1.704 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Mean Corpuscular Volume, Day 16 (fL) | -1.58 fL | Standard Deviation 5.278 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Mean Corpuscular Volume, Week 12 (fL) | 2.53 fL | Standard Deviation 4.957 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Mean Corpuscular Volume, Week 6 (fL) | -0.53 fL | Standard Deviation 73.486 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Mean Corpuscular Volume, Week 24 (fL) | 1.30 fL | Standard Deviation 4.577 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Mean Corpuscular Volume, Day 16 (fL) | -2.55 fL | Standard Deviation 6.125 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Mean Corpuscular Volume, Week 24 (fL) | -2.26 fL | Standard Deviation 8.719 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Mean Corpuscular Volume, Week 6 (fL) | 0.45 fL | Standard Deviation 7.486 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Mean Corpuscular Volume, Day 16 (fL) | -0.26 fL | Standard Deviation 4.713 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Mean Corpuscular Volume, Week 12 (fL) | -1.05 fL | Standard Deviation 5.025 |
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.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Mean Corpuscular Haemoglobin, Day 16 (pg) | 0.13 pg | Standard Deviation 0.862 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Mean Corpuscular Haemoglobin, Week 6 (pg) | 0.23 pg | Standard Deviation 0.862 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Mean Corpuscular Haemoglobin, Week 12 (pg) | 0.23 pg | Standard Deviation 1.056 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Mean Corpuscular Haemoglobin, Week 24 (pg) | 1.35 pg | Standard Deviation 1.212 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Mean Corpuscular Haemoglobin, Day 16 (pg) | -0.97 pg | Standard Deviation 1.632 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Mean Corpuscular Haemoglobin, Week 6 (pg) | 0.33 pg | Standard Deviation 1.109 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Mean Corpuscular Haemoglobin, Week 24 (pg) | 0.40 pg | Standard Deviation 0.985 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Mean Corpuscular Haemoglobin, Week 12 (pg) | 0.05 pg | Standard Deviation 1.015 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Mean Corpuscular Haemoglobin, Week 24 (pg) | 1.33 pg | Standard Deviation 3.822 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Mean Corpuscular Haemoglobin, Day 16 (pg) | -1.15 pg | Standard Deviation 1.353 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Mean Corpuscular Haemoglobin, Week 6 (pg) | 0.05 pg | Standard Deviation 2.603 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Mean Corpuscular Haemoglobin, Week 12 (pg) | 0.83 pg | Standard Deviation 2.403 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Mean Corpuscular Haemoglobin, Day 16 (pg) | 0.22 pg | Standard Deviation 2.586 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Mean Corpuscular Haemoglobin, Week 24 (pg) | -0.76 pg | Standard Deviation 3.062 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Mean Corpuscular Haemoglobin, Week 6 (pg) | -0.17 pg | Standard Deviation 1.797 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Mean Corpuscular Haemoglobin, Week 12 (pg) | -2.05 pg | Standard Deviation 4.155 |
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.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Haematocrit, Day 16 (%) | 2.13 Percetange | Standard Deviation 1.907 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Haematocrit, Week 6 (%) | 0.83 Percetange | Standard Deviation 1.489 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Haematocrit, Week 12 (%) | 6.83 Percetange | Standard Deviation 1.489 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Laboratory Results | Haematocrit, Week 24 (%) | 3.48 Percetange | Standard Deviation 5.067 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Haematocrit, Week 6 (%) | -2.23 Percetange | Standard Deviation 5.229 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Haematocrit, Week 12 (%) | -2.23 Percetange | Standard Deviation 5.229 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Haematocrit, Week 24 (%) | -0.40 Percetange | Standard Deviation 6.391 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Laboratory Results | Haematocrit, Day 16 (%) | -1.62 Percetange | Standard Deviation 3.029 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Haematocrit, Week 12 (%) | -1.58 Percetange | Standard Deviation 3.04 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Haematocrit, Week 6 (%) | -1.58 Percetange | Standard Deviation 3.04 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Haematocrit, Week 24 (%) | -1.28 Percetange | Standard Deviation 2.313 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Laboratory Results | Haematocrit, Day 16 (%) | 0.80 Percetange | Standard Deviation 4.249 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Haematocrit, Week 24 (%) | -4.42 Percetange | Standard Deviation 5.966 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Haematocrit, Week 6 (%) | -3.25 Percetange | Standard Deviation 2.924 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Haematocrit, Day 16 (%) | -3.64 Percetange | Standard Deviation 3.281 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Laboratory Results | Haematocrit, Week 12 (%) | -3.25 Percetange | Standard Deviation 2.924 |
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.
Time frame: 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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 2 - NOX66 800mg Daily | 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) | 5 Participants |
| Cohort 2 - NOX66 800mg Daily | 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 |
| Cohort 2 - NOX66 800mg Daily | 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) | 5 Participants |
| Cohort 2 - NOX66 800mg Daily | 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 |
| Cohort 2 - NOX66 800mg Daily | 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 | 3 Participants |
| Cohort 2 - NOX66 800mg Daily | 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) | 3 Participants |
| Cohort 3 - NOX66 1200mg Daily | 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 |
| Cohort 3 - NOX66 1200mg Daily | 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 |
| Cohort 3 - NOX66 1200mg Daily | 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 |
| Cohort 3 - NOX66 1200mg Daily | 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) | 2 Participants |
| Cohort 3 - NOX66 1200mg Daily | 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) | 2 Participants |
| Cohort 3 - NOX66 1200mg Daily | 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) | 1 Participants |
| Cohort 4 - NOX66 1200mg Daily | 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 |
| Cohort 4 - NOX66 1200mg Daily | 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) | 1 Participants |
| Cohort 4 - NOX66 1200mg Daily | 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 |
| Cohort 4 - NOX66 1200mg Daily | 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 | 6 Participants |
| Cohort 4 - NOX66 1200mg Daily | 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) | 9 Participants |
| Cohort 4 - NOX66 1200mg Daily | 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) | 9 Participants |
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.
Time frame: 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
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Genitourinary Exam, Day 16 | Improved | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Lymphatic Exam, Week 6 | Worsened | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Musculoskeletal Exam, Week 12 | Worsened | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | HEENT Exam, Week 12 | Improved | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Musculoskeletal Exam, Week 6 | Improved | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Pulmonary Exam, Day 2 | Worsened | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Gastrointestinal Exam, Week 24 | Worsened | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Genitourinary Exam, Week 24 | Improved | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Musculoskeletal Exam, Week 6 | Worsened | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | HEENT Exam, Week 24 | Worsened | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Genitourinary Exam, Day 2 | Worsened | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | HEENT Exam, Week 6 | Worsened | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Musculoskeletal Exam, Week 24 | Improved | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Genitourinary Exam, Day 2 | Improved | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Pulmonary Exam, Day 2 | Improved | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Neurological Exam, Day 16 | Improved | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Cardiovascular Exam, Week 6 | Worsened | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Pulmonary Exam, Day 16 | Worsened | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Cardiovascular Exam, Day 16 | Improved | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Lymphatic Exam, Day 2 | Improved | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | HEENT Exam, Week 6 | Improved | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Neurological Exam, Day 16 | Worsened | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Cardiovascular Exam, Week 24 | Worsened | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Musculoskeletal Exam, Day 2 | Improved | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Abdominal Exam, Week 6 | Improved | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Neurological Exam, Week 6 | Improved | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | HEENT Exam, Day 16 | Worsened | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Neurological Exam, Week 12 | Worsened | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Cardiovascular Exam, Week 12 | Improved | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Neurological Exam, Week 24 | Improved | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Lymphatic Exam, Week 12 | Improved | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Cardiovascular Exam, Day 2 | Worsened | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Abdominal Exam, Week 6 | Worsened | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Neurological Exam, Week 24 | Worsened | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Gastrointestinal Exam, Week 12 | Worsened | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Lymphatic Exam, Day 16 | Improved | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | HEENT Exam, Day 16 | Improved | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Cardiovascular Exam, Day 16 | Worsened | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Other Exam, Day 16 | Worsened | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Genitourinary Exam, Day 16 | Worsened | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | HEENT Exam, Day 2 | Worsened | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Other Exam, Week 6 | Improved | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Pulmonary Exam, Week 6 | Improved | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Gastrointestinal Exam, Week 12 | Improved | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | HEENT Exam, Week 24 | Improved | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Abdominal Exam, Week 12 | Worsened | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Pulmonary Exam, Week 12 | Improved | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Gastrointestinal Exam, Week 24 | Improved | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Cardiovascular Exam, Week 12 | Worsened | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Dermatologic Exam, Day 16 | Worsened | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Dermatologic Exam, Week 6 | Improved | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Gastrointestinal Exam, Week 6 | Improved | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Pulmonary Exam, Day 16 | Improved | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Abdominal Exam, Week 12 | Improved | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | HEENT Exam, Day 2 | Improved | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Dermatologic Exam, Week 6 | Worsened | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Dermatologic Exam, Day 2 | Improved | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Lymphatic Exam, Day 2 | Worsened | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Dermatologic Exam, Week 24 | Improved | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Cardiovascular Exam, Week 6 | Improved | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Cardiovascular Exam, Week 24 | Improved | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | HEENT Exam, Week 12 | Worsened | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Musculoskeletal Exam, Day 16 | Worsened | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Genitourinary Exam, Week 24 | Worsened | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Dermatologic Exam, Week 24 | Worsened | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Gastrointestinal Exam, Day 2 | Worsened | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Genitourinary Exam, Week 12 | Worsened | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Musculoskeletal Exam, Week 12 | Improved | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Genitourinary Exam, Week 12 | Improved | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Gastrointestinal Exam, Day 16 | Worsened | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Other Exam, Day 16 | Improved | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Other Exam, Day 2 | Worsened | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Musculoskeletal Exam, Day 16 | Improved | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Other Exam, Day 2 | Improved | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Musculoskeletal Exam, Week 24 | Worsened | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Neurological Exam, Week 12 | Improved | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Neurological Exam, Day 2 | Improved | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Dermatologic Exam, Day 2 | Worsened | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Neurological Exam, Week 6 | Worsened | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Neurological Exam, Day 2 | Worsened | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Genitourinary Exam, Week 6 | Worsened | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Dermatologic Exam, Day 16 | Improved | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Abdominal Exam, Day 2 | Improved | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Lymphatic Exam, Week 24 | Improved | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Genitourinary Exam, Week 6 | Improved | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Pulmonary Exam, Week 24 | Worsened | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Gastrointestinal Exam, Week 6 | Worsened | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Abdominal Exam, Day 2 | Worsened | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Abdominal Exam, Day 16 | Improved | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Lymphatic Exam, Week 12 | Worsened | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Pulmonary Exam, Week 24 | Improved | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Abdominal Exam, Week 24 | Worsened | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Lymphatic Exam, Week 6 | Improved | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Pulmonary Exam, Week 12 | Worsened | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Abdominal Exam, Day 16 | Worsened | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Lymphatic Exam, Day 16 | Worsened | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Gastrointestinal Exam, Day 16 | Improved | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Abdominal Exam, Week 24 | Improved | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Gastrointestinal Exam, Day 2 | Improved | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Dermatologic Exam, Week 12 | Worsened | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Other Exam, Week 24 | Worsened | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Dermatologic Exam, Week 12 | Improved | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Pulmonary Exam, Week 6 | Worsened | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Other Exam, Week 24 | Improved | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Other Exam, Week 12 | Worsened | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Cardiovascular Exam, Day 2 | Improved | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Other Exam, Week 12 | Improved | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Other Exam, Week 6 | Worsened | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Musculoskeletal Exam, Day 2 | Worsened | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Lymphatic Exam, Week 24 | Worsened | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Pulmonary Exam, Week 12 | Worsened | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Pulmonary Exam, Week 24 | No change | 3 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Cardiovascular Exam, Day 2 | No change | 5 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Dermatologic Exam, Day 2 | Worsened | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Abdominal Exam, Day 2 | Improved | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Abdominal Exam, Day 2 | No change | 5 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Abdominal Exam, Day 16 | Improved | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Abdominal Exam, Day 16 | No change | 6 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Abdominal Exam, Day 16 | Worsened | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Abdominal Exam, Week 24 | Improved | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Abdominal Exam, Week 24 | No change | 3 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Abdominal Exam, Week 24 | Worsened | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Musculoskeletal Exam, Day 2 | Worsened | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Musculoskeletal Exam, Week 24 | No change | 3 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Musculoskeletal Exam, Week 24 | Worsened | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Neurological Exam, Day 2 | Improved | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Neurological Exam, Day 2 | No change | 5 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Neurological Exam, Day 2 | Worsened | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Neurological Exam, Week 6 | No change | 4 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Neurological Exam, Week 6 | Worsened | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Neurological Exam, Week 12 | Improved | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Neurological Exam, Week 12 | No change | 4 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Other Exam, Day 2 | Improved | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Other Exam, Day 2 | No change | 3 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Other Exam, Day 2 | Worsened | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Other Exam, Day 16 | Improved | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Other Exam, Week 6 | Worsened | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Other Exam, Week 12 | Improved | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Other Exam, Week 12 | No change | 2 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Other Exam, Week 12 | Worsened | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Other Exam, Week 24 | Improved | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Dermatologic Exam, Week 12 | Improved | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | 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 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Dermatologic Exam, Week 12 | Worsened | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Gastrointestinal Exam, Day 2 | Improved | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | 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 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Gastrointestinal Exam, Day 16 | Improved | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Pulmonary Exam, Week 12 | Improved | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | 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 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Genitourinary Exam, Day 16 | No change | 5 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Pulmonary Exam, Week 24 | Improved | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Pulmonary Exam, Week 24 | Worsened | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Genitourinary Exam, Day 16 | Worsened | 1 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Genitourinary Exam, Week 6 | Improved | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Lymphatic Exam, Day 16 | Improved | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Lymphatic Exam, Day 16 | No change | 6 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Lymphatic Exam, Day 16 | Worsened | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Lymphatic Exam, Week 6 | Improved | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | 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 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Lymphatic Exam, Week 12 | Worsened | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Lymphatic Exam, Week 24 | Improved | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Lymphatic Exam, Week 24 | No change | 3 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Lymphatic Exam, Week 24 | Worsened | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Dermatologic Exam, Week 24 | Worsened | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Gastrointestinal Exam, Day 2 | Worsened | 1 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Gastrointestinal Exam, Day 16 | No change | 5 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Lymphatic Exam, Day 2 | No change | 5 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Genitourinary Exam, Week 24 | No change | 3 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Gastrointestinal Exam, Day 16 | Worsened | 1 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Dermatologic Exam, Week 6 | Improved | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Gastrointestinal Exam, Week 6 | Improved | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Cardiovascular Exam, Week 24 | No change | 3 Participants |
| Cohort 2 - NOX66 800mg Daily | 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 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Other Exam, Week 24 | Worsened | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Genitourinary Exam, Week 24 | Improved | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Pulmonary Exam, Day 2 | Improved | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Genitourinary Exam, Week 12 | Worsened | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Pulmonary Exam, Day 2 | No change | 5 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Cardiovascular Exam, Week 24 | Worsened | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Pulmonary Exam, Day 2 | Worsened | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Gastrointestinal Exam, Week 6 | Worsened | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Cardiovascular Exam, Day 16 | Improved | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Lymphatic Exam, Day 2 | Improved | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | 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 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Gastrointestinal Exam, Week 12 | Improved | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Pulmonary Exam, Day 16 | Improved | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Dermatologic Exam, Day 2 | Improved | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Genitourinary Exam, Week 12 | Improved | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Pulmonary Exam, Day 16 | No change | 6 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Abdominal Exam, Day 2 | Worsened | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Genitourinary Exam, Week 6 | Worsened | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | 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 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Pulmonary Exam, Day 16 | Worsened | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | 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 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Gastrointestinal Exam, Week 12 | Worsened | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Dermatologic Exam, Day 2 | No change | 5 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Gastrointestinal Exam, Week 24 | Improved | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Pulmonary Exam, Week 6 | Improved | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Lymphatic Exam, Week 12 | Improved | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Pulmonary Exam, Week 6 | Worsened | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | 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 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | HEENT Exam, Week 24 | Worsened | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Genitourinary Exam, Day 16 | Improved | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Dermatologic Exam, Day 16 | Improved | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Gastrointestinal Exam, Week 24 | No change | 3 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Genitourinary Exam, Day 2 | Worsened | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Gastrointestinal Exam, Week 24 | Worsened | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Genitourinary Exam, Day 2 | Improved | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Genitourinary Exam, Day 2 | No change | 5 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Dermatologic Exam, Day 16 | No change | 5 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Cardiovascular Exam, Day 16 | No change | 6 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | HEENT Exam, Week 24 | No change | 3 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Abdominal Exam, Week 6 | Improved | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | 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 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Abdominal Exam, Week 6 | Worsened | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | HEENT Exam, Week 24 | Improved | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Abdominal Exam, Week 12 | Improved | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | 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 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Cardiovascular Exam, Day 16 | Worsened | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Abdominal Exam, Week 12 | Worsened | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Cardiovascular Exam, Day 2 | Improved | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Musculoskeletal Exam, Day 16 | Improved | 1 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Lymphatic Exam, Week 6 | Worsened | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | HEENT Exam, Week 12 | Worsened | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Musculoskeletal Exam, Day 16 | No change | 5 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Musculoskeletal Exam, Day 16 | Worsened | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Cardiovascular Exam, Week 6 | Improved | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | 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 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Musculoskeletal Exam, Week 12 | Improved | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Musculoskeletal Exam, Day 2 | Improved | 1 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Musculoskeletal Exam, Week 12 | No change | 3 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | HEENT Exam, Week 12 | Improved | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Musculoskeletal Exam, Week 12 | Worsened | 1 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Musculoskeletal Exam, Week 6 | Improved | 1 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Musculoskeletal Exam, Week 6 | No change | 3 Participants |
| Cohort 2 - NOX66 800mg Daily | 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 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | HEENT Exam, Week 6 | Worsened | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Musculoskeletal Exam, Week 6 | Worsened | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | 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 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Musculoskeletal Exam, Week 24 | Improved | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | 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 |
| Cohort 2 - NOX66 800mg Daily | 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 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Neurological Exam, Day 16 | Improved | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | HEENT Exam, Week 6 | Improved | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Neurological Exam, Day 16 | No change | 6 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Cardiovascular Exam, Week 6 | Worsened | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Neurological Exam, Day 16 | Worsened | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | HEENT Exam, Day 16 | Worsened | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Neurological Exam, Week 6 | Improved | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Neurological Exam, Week 12 | Worsened | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | HEENT Exam, Day 16 | No change | 6 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Neurological Exam, Week 24 | Improved | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Cardiovascular Exam, Week 12 | Improved | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | 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 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | HEENT Exam, Day 16 | Improved | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Neurological Exam, Week 24 | Worsened | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Other Exam, Day 16 | No change | 3 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | HEENT Exam, Day 2 | Worsened | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Other Exam, Day 16 | Worsened | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | 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 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Other Exam, Week 6 | Improved | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Cardiovascular Exam, Day 2 | Worsened | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | HEENT Exam, Day 2 | No change | 5 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Other Exam, Week 6 | No change | 2 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Lymphatic Exam, Day 2 | Worsened | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Other Exam, Week 24 | No change | 2 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Dermatologic Exam, Day 16 | Worsened | 1 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Cardiovascular Exam, Week 12 | Worsened | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | HEENT Exam, Day 2 | Improved | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | 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 |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Dermatologic Exam, Week 6 | Worsened | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Dermatologic Exam, Week 24 | Improved | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Genitourinary Exam, Week 24 | Worsened | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Dermatologic Exam, Week 24 | No change | 3 Participants |
| Cohort 2 - NOX66 800mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Cardiovascular Exam, Week 24 | Improved | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Musculoskeletal Exam, Day 2 | No change | 3 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Abdominal Exam, Day 2 | Worsened | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Abdominal Exam, Week 12 | Improved | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | 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 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Cardiovascular Exam, Day 2 | Worsened | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Cardiovascular Exam, Day 16 | Improved | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | 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 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Cardiovascular Exam, Day 16 | Worsened | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Cardiovascular Exam, Week 6 | Improved | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | 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 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Cardiovascular Exam, Week 6 | Worsened | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Cardiovascular Exam, Week 12 | Improved | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | 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 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Cardiovascular Exam, Week 12 | Worsened | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Cardiovascular Exam, Week 24 | Improved | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | 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 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Cardiovascular Exam, Week 24 | Worsened | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Dermatologic Exam, Day 2 | Improved | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | 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 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Dermatologic Exam, Day 16 | Improved | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | 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 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Abdominal Exam, Week 6 | Improved | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | 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 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Abdominal Exam, Week 6 | Worsened | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | 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 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Abdominal Exam, Week 12 | Worsened | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Musculoskeletal Exam, Day 16 | Improved | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Musculoskeletal Exam, Day 16 | No change | 3 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Musculoskeletal Exam, Day 16 | Worsened | 1 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Musculoskeletal Exam, Week 12 | Improved | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Musculoskeletal Exam, Week 12 | No change | 3 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Musculoskeletal Exam, Week 12 | Worsened | 1 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Musculoskeletal Exam, Week 6 | No change | 3 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Musculoskeletal Exam, Week 6 | Worsened | 1 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Musculoskeletal Exam, Week 24 | Improved | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Neurological Exam, Day 16 | Improved | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Neurological Exam, Day 16 | No change | 4 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Neurological Exam, Day 16 | Worsened | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Neurological Exam, Week 6 | Improved | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Neurological Exam, Week 12 | Worsened | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Neurological Exam, Week 24 | Improved | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Neurological Exam, Week 24 | No change | 4 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Other Exam, Day 16 | Improved | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | 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 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Other Exam, Day 16 | Worsened | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Other Exam, Week 6 | Improved | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Other Exam, Week 24 | Improved | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | 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 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Dermatologic Exam, Week 6 | Improved | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | 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 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Dermatologic Exam, Week 6 | Worsened | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Dermatologic Exam, Week 24 | Improved | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | 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 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Dermatologic Exam, Week 24 | Worsened | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | 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 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Gastrointestinal Exam, Day 16 | Worsened | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Gastrointestinal Exam, Week 6 | Improved | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | 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 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Other Exam, Week 24 | Worsened | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Pulmonary Exam, Day 2 | Improved | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | 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 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Gastrointestinal Exam, Week 6 | Worsened | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Pulmonary Exam, Day 2 | Worsened | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Gastrointestinal Exam, Week 12 | Improved | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Pulmonary Exam, Day 16 | Improved | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | 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 |
| Cohort 3 - NOX66 1200mg Daily | 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 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Pulmonary Exam, Day 16 | Worsened | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Gastrointestinal Exam, Week 12 | Worsened | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Pulmonary Exam, Week 6 | Improved | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | 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 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Gastrointestinal Exam, Week 24 | Improved | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | 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 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Gastrointestinal Exam, Week 24 | Worsened | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Genitourinary Exam, Day 2 | Improved | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | 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 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Genitourinary Exam, Day 2 | Worsened | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Pulmonary Exam, Week 6 | Worsened | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Genitourinary Exam, Week 6 | Improved | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | 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 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Genitourinary Exam, Week 6 | Worsened | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Genitourinary Exam, Week 12 | Improved | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | 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 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Genitourinary Exam, Week 12 | Worsened | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Genitourinary Exam, Week 24 | Improved | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | 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 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Genitourinary Exam, Week 24 | Worsened | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | HEENT Exam, Day 2 | Improved | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | 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 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | HEENT Exam, Day 2 | Worsened | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | HEENT Exam, Day 16 | Improved | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | 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 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | HEENT Exam, Day 16 | Worsened | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | HEENT Exam, Week 6 | Improved | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | 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 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | HEENT Exam, Week 6 | Worsened | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | HEENT Exam, Week 12 | Improved | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | 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 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | HEENT Exam, Week 12 | Worsened | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | HEENT Exam, Week 24 | Improved | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | 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 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | HEENT Exam, Week 24 | Worsened | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Lymphatic Exam, Day 2 | Improved | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | 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 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Lymphatic Exam, Day 2 | Worsened | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Lymphatic Exam, Week 6 | Improved | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | 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 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Lymphatic Exam, Week 6 | Worsened | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Lymphatic Exam, Week 12 | Improved | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Lymphatic Exam, Week 24 | Worsened | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Musculoskeletal Exam, Day 2 | Improved | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Genitourinary Exam, Day 16 | Improved | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | 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 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Abdominal Exam, Day 16 | Improved | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Abdominal Exam, Week 24 | Improved | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Musculoskeletal Exam, Week 6 | Improved | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | 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 |
| Cohort 3 - NOX66 1200mg Daily | 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 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Pulmonary Exam, Week 24 | Improved | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Gastrointestinal Exam, Day 2 | Improved | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | 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 |
| Cohort 3 - NOX66 1200mg Daily | 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 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Lymphatic Exam, Week 24 | Improved | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Other Exam, Week 12 | Improved | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Lymphatic Exam, Week 12 | Worsened | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Pulmonary Exam, Week 24 | Worsened | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | 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 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Dermatologic Exam, Week 12 | Improved | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Genitourinary Exam, Day 16 | Worsened | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Gastrointestinal Exam, Day 2 | Worsened | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Neurological Exam, Day 2 | No change | 4 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Other Exam, Week 6 | Worsened | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Neurological Exam, Day 2 | Worsened | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | 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 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Abdominal Exam, Day 2 | Improved | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Neurological Exam, Week 6 | No change | 4 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Dermatologic Exam, Day 16 | Worsened | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Neurological Exam, Day 2 | Improved | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Gastrointestinal Exam, Day 16 | Improved | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Neurological Exam, Week 6 | Worsened | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Lymphatic Exam, Day 16 | Worsened | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Abdominal Exam, Day 16 | Worsened | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | 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 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Neurological Exam, Week 12 | Improved | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Pulmonary Exam, Week 12 | Improved | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Musculoskeletal Exam, Week 24 | Worsened | 1 Participants |
| Cohort 3 - NOX66 1200mg Daily | 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 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Neurological Exam, Week 12 | No change | 4 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Other Exam, Week 12 | Worsened | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Neurological Exam, Week 24 | Worsened | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Cardiovascular Exam, Day 2 | Improved | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | 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 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Dermatologic Exam, Day 2 | Worsened | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Other Exam, Day 2 | Improved | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Abdominal Exam, Week 24 | Worsened | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Musculoskeletal Exam, Week 24 | No change | 3 Participants |
| Cohort 3 - NOX66 1200mg Daily | 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 |
| Cohort 3 - NOX66 1200mg Daily | 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 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Dermatologic Exam, Week 12 | Worsened | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Pulmonary Exam, Week 12 | Worsened | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Lymphatic Exam, Day 16 | Improved | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Other Exam, Day 2 | Worsened | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | 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 |
| Cohort 3 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Musculoskeletal Exam, Day 2 | Worsened | 1 Participants |
| Cohort 3 - NOX66 1200mg Daily | 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 |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Other Exam, Day 2 | Improved | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Lymphatic Exam, Week 24 | No change | 11 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Other Exam, Day 2 | No change | 6 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Musculoskeletal Exam, Day 2 | Worsened | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Other Exam, Day 2 | Worsened | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Lymphatic Exam, Day 16 | Improved | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Other Exam, Week 6 | No change | 6 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Musculoskeletal Exam, Day 2 | No change | 11 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Other Exam, Week 24 | No change | 6 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Other Exam, Week 6 | Worsened | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Cardiovascular Exam, Day 2 | Improved | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Other Exam, Week 12 | Improved | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Other Exam, Week 12 | No change | 6 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Abdominal Exam, Week 24 | Worsened | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Lymphatic Exam, Day 16 | No change | 11 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Other Exam, Week 12 | Worsened | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Musculoskeletal Exam, Week 6 | Improved | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Dermatologic Exam, Week 6 | Worsened | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Abdominal Exam, Week 24 | No change | 11 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Lymphatic Exam, Week 24 | Improved | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Dermatologic Exam, Week 12 | Improved | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Dermatologic Exam, Week 12 | No change | 11 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Abdominal Exam, Week 24 | Improved | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Lymphatic Exam, Day 16 | Worsened | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Dermatologic Exam, Week 12 | Worsened | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Dermatologic Exam, Week 24 | Worsened | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Gastrointestinal Exam, Day 2 | Improved | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Abdominal Exam, Week 12 | Worsened | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Gastrointestinal Exam, Day 2 | No change | 11 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Gastrointestinal Exam, Day 2 | Worsened | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Abdominal Exam, Day 16 | Worsened | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Gastrointestinal Exam, Day 16 | Improved | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Pulmonary Exam, Week 12 | Improved | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Abdominal Exam, Day 16 | No change | 11 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Lymphatic Exam, Week 12 | No change | 11 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Pulmonary Exam, Week 12 | No change | 11 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Abdominal Exam, Day 16 | Improved | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Pulmonary Exam, Week 12 | Worsened | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Genitourinary Exam, Day 16 | Improved | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Abdominal Exam, Day 2 | No change | 11 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Genitourinary Exam, Day 2 | Improved | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Pulmonary Exam, Week 24 | Improved | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Pulmonary Exam, Week 24 | No change | 11 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Abdominal Exam, Day 2 | Improved | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Pulmonary Exam, Week 24 | Worsened | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Lymphatic Exam, Week 12 | Worsened | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Neurological Exam, Day 2 | No change | 11 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Genitourinary Exam, Day 16 | Worsened | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Neurological Exam, Day 2 | Improved | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Neurological Exam, Week 6 | No change | 11 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Gastrointestinal Exam, Day 16 | Worsened | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Neurological Exam, Week 6 | Worsened | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Musculoskeletal Exam, Week 24 | Worsened | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Genitourinary Exam, Week 6 | Improved | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Neurological Exam, Week 12 | Improved | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Dermatologic Exam, Day 2 | Worsened | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Neurological Exam, Week 12 | No change | 11 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Neurological Exam, Week 24 | Worsened | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Musculoskeletal Exam, Week 24 | No change | 11 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Genitourinary Exam, Week 24 | Improved | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Gastrointestinal Exam, Week 6 | Improved | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Gastrointestinal Exam, Day 16 | No change | 11 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Lymphatic Exam, Day 2 | Worsened | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Genitourinary Exam, Week 24 | No change | 11 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Dermatologic Exam, Week 24 | No change | 11 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Dermatologic Exam, Week 24 | Improved | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Cardiovascular Exam, Week 12 | Improved | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Genitourinary Exam, Week 24 | Worsened | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Dermatologic Exam, Week 6 | No change | 11 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Dermatologic Exam, Week 6 | Improved | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Dermatologic Exam, Day 16 | Worsened | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | HEENT Exam, Day 2 | Improved | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Other Exam, Week 24 | Improved | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Other Exam, Week 6 | Improved | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Lymphatic Exam, Week 6 | Improved | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | HEENT Exam, Day 2 | No change | 11 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Other Exam, Day 16 | Worsened | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Other Exam, Day 16 | No change | 6 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Cardiovascular Exam, Week 6 | Worsened | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | HEENT Exam, Day 2 | Worsened | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Other Exam, Day 16 | Improved | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Neurological Exam, Week 24 | No change | 11 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Cardiovascular Exam, Week 6 | No change | 11 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | HEENT Exam, Day 16 | Improved | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Neurological Exam, Week 24 | Improved | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Neurological Exam, Week 12 | Worsened | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Abdominal Exam, Day 2 | Worsened | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | HEENT Exam, Day 16 | No change | 11 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Neurological Exam, Week 6 | Improved | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Neurological Exam, Day 16 | Worsened | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Lymphatic Exam, Week 6 | No change | 11 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | HEENT Exam, Day 16 | Worsened | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Neurological Exam, Day 16 | No change | 11 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Neurological Exam, Day 16 | Improved | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Cardiovascular Exam, Week 6 | Improved | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | HEENT Exam, Week 6 | Improved | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Neurological Exam, Day 2 | Worsened | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Musculoskeletal Exam, Week 24 | Improved | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Cardiovascular Exam, Day 16 | Worsened | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | HEENT Exam, Week 6 | No change | 11 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Musculoskeletal Exam, Week 6 | Worsened | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Musculoskeletal Exam, Week 6 | No change | 11 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Musculoskeletal Exam, Day 2 | Improved | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | HEENT Exam, Week 6 | Worsened | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Musculoskeletal Exam, Week 12 | Worsened | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Musculoskeletal Exam, Week 12 | No change | 10 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Lymphatic Exam, Week 6 | Worsened | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | HEENT Exam, Week 12 | Improved | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Musculoskeletal Exam, Week 12 | Improved | 1 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Musculoskeletal Exam, Day 16 | Worsened | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Cardiovascular Exam, Day 16 | No change | 11 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | HEENT Exam, Week 12 | No change | 11 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Musculoskeletal Exam, Day 16 | No change | 11 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Musculoskeletal Exam, Day 16 | Improved | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Cardiovascular Exam, Day 16 | Improved | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | HEENT Exam, Week 12 | Worsened | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Abdominal Exam, Week 12 | No change | 11 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Abdominal Exam, Week 6 | Worsened | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Abdominal Exam, Week 12 | Improved | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | HEENT Exam, Week 24 | Improved | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Abdominal Exam, Week 6 | No change | 11 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Dermatologic Exam, Day 16 | No change | 11 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Lymphatic Exam, Week 12 | Improved | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | HEENT Exam, Week 24 | No change | 11 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Dermatologic Exam, Day 16 | Improved | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Dermatologic Exam, Day 2 | No change | 11 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Cardiovascular Exam, Day 2 | Worsened | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | HEENT Exam, Week 24 | Worsened | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Dermatologic Exam, Day 2 | Improved | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Cardiovascular Exam, Week 24 | Worsened | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Genitourinary Exam, Day 2 | No change | 11 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Gastrointestinal Exam, Week 24 | Worsened | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Gastrointestinal Exam, Week 24 | No change | 11 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Abdominal Exam, Week 6 | Improved | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Genitourinary Exam, Day 2 | Worsened | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Gastrointestinal Exam, Week 24 | Improved | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Pulmonary Exam, Week 6 | No change | 11 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Pulmonary Exam, Week 6 | Improved | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Lymphatic Exam, Day 2 | Improved | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Pulmonary Exam, Week 6 | Worsened | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Gastrointestinal Exam, Week 12 | Worsened | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Genitourinary Exam, Day 16 | No change | 11 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Pulmonary Exam, Day 16 | Worsened | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Cardiovascular Exam, Week 24 | No change | 11 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Gastrointestinal Exam, Week 12 | No change | 11 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Cardiovascular Exam, Week 24 | Improved | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Genitourinary Exam, Week 6 | No change | 11 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Pulmonary Exam, Day 16 | No change | 11 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Lymphatic Exam, Week 24 | Worsened | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Genitourinary Exam, Week 6 | Worsened | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Pulmonary Exam, Day 16 | Improved | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Gastrointestinal Exam, Week 12 | Improved | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Lymphatic Exam, Day 2 | No change | 11 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Genitourinary Exam, Week 12 | Improved | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Gastrointestinal Exam, Week 6 | Worsened | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Pulmonary Exam, Day 2 | Worsened | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Cardiovascular Exam, Week 12 | Worsened | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Genitourinary Exam, Week 12 | No change | 11 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Pulmonary Exam, Day 2 | No change | 11 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Pulmonary Exam, Day 2 | Improved | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Cardiovascular Exam, Week 12 | No change | 11 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Genitourinary Exam, Week 12 | Worsened | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Other Exam, Week 24 | Worsened | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Gastrointestinal Exam, Week 6 | No change | 11 Participants |
| Cohort 4 - NOX66 1200mg Daily | Assessment of Change in Physical Appearance (Physical Exam) by Measuring HEENT, Gastrointestinal, Abdominal Status at Multiple Timepoints | Cardiovascular Exam, Day 2 | No change | 11 Participants |
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.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 1 - NOX66 400mg Daily | 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 |
| Cohort 2 - NOX66 800mg Daily | Change in Overall Pain Score Using the Brief Pain Inventory - Short Form (BPI-SF) | Week 24 | -80.992 Percentage change from baseline in score | Standard Deviation 32.9233 |
| Cohort 2 - NOX66 800mg Daily | Change in Overall Pain Score Using the Brief Pain Inventory - Short Form (BPI-SF) | Day 16 | 32.737 Percentage change from baseline in score | Standard Deviation 103.7459 |
| Cohort 2 - NOX66 800mg Daily | Change in Overall Pain Score Using the Brief Pain Inventory - Short Form (BPI-SF) | Week 6 | -47.815 Percentage change from baseline in score | Standard Deviation 35.0069 |
| Cohort 2 - NOX66 800mg Daily | Change in Overall Pain Score Using the Brief Pain Inventory - Short Form (BPI-SF) | Week 12 | -29.175 Percentage change from baseline in score | Standard Deviation 82.3088 |
| Cohort 3 - NOX66 1200mg Daily | Change in Overall Pain Score Using the Brief Pain Inventory - Short Form (BPI-SF) | Week 12 | 42.8 Percentage change from baseline in score | Standard Deviation 44.46 |
| Cohort 3 - NOX66 1200mg Daily | Change in Overall Pain Score Using the Brief Pain Inventory - Short Form (BPI-SF) | Day 16 | 3.6 Percentage change from baseline in score | Standard Deviation 32.3 |
| Cohort 3 - NOX66 1200mg Daily | Change in Overall Pain Score Using the Brief Pain Inventory - Short Form (BPI-SF) | Week 24 | -38.4 Percentage change from baseline in score | Standard Deviation 35.16 |
| Cohort 3 - NOX66 1200mg Daily | Change in Overall Pain Score Using the Brief Pain Inventory - Short Form (BPI-SF) | Week 6 | -44.1 Percentage change from baseline in score | Standard Deviation 44.36 |
| Cohort 4 - NOX66 1200mg Daily | Change in Overall Pain Score Using the Brief Pain Inventory - Short Form (BPI-SF) | Week 6 | -41.8 Percentage change from baseline in score | Standard Deviation 42.28 |
| Cohort 4 - NOX66 1200mg Daily | Change in Overall Pain Score Using the Brief Pain Inventory - Short Form (BPI-SF) | Day 16 | -37.2 Percentage change from baseline in score | Standard Deviation 37.92 |
| Cohort 4 - NOX66 1200mg Daily | Change in Overall Pain Score Using the Brief Pain Inventory - Short Form (BPI-SF) | Week 24 | -68.6 Percentage change from baseline in score | Standard Deviation 49.04 |
| Cohort 4 - NOX66 1200mg Daily | Change in Overall Pain Score Using the Brief Pain Inventory - Short Form (BPI-SF) | Week 12 | -37.0 Percentage change from baseline in score | Standard Deviation 47.51 |
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
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 - NOX66 400mg Daily | Change in Prostate Specific Antigen (PSA) Levels | Week 6 | 17.79 Percentage change from baseline in PSA | Standard Deviation 42.116 |
| Cohort 1 - NOX66 400mg Daily | Change in Prostate Specific Antigen (PSA) Levels | Week 24 | 333.51 Percentage change from baseline in PSA | Standard Deviation 357.538 |
| Cohort 1 - NOX66 400mg Daily | Change in Prostate Specific Antigen (PSA) Levels | Week 12 | 35.75 Percentage change from baseline in PSA | Standard Deviation 31.61 |
| Cohort 2 - NOX66 800mg Daily | Change in Prostate Specific Antigen (PSA) Levels | Week 6 | -46.67 Percentage change from baseline in PSA | Standard Deviation 27.358 |
| Cohort 2 - NOX66 800mg Daily | Change in Prostate Specific Antigen (PSA) Levels | Week 24 | -14.85 Percentage change from baseline in PSA | Standard Deviation 62.764 |
| Cohort 2 - NOX66 800mg Daily | Change in Prostate Specific Antigen (PSA) Levels | Week 12 | -53.26 Percentage change from baseline in PSA | Standard Deviation 31.766 |
| Cohort 3 - NOX66 1200mg Daily | Change in Prostate Specific Antigen (PSA) Levels | Week 12 | 14.82 Percentage change from baseline in PSA | Standard Deviation 138.637 |
| Cohort 3 - NOX66 1200mg Daily | Change in Prostate Specific Antigen (PSA) Levels | Week 6 | 0.29 Percentage change from baseline in PSA | Standard Deviation 41.424 |
| Cohort 3 - NOX66 1200mg Daily | Change in Prostate Specific Antigen (PSA) Levels | Week 24 | 374.20 Percentage change from baseline in PSA | Standard Deviation 518.309 |
| Cohort 4 - NOX66 1200mg Daily | Change in Prostate Specific Antigen (PSA) Levels | Week 6 | -19.49 Percentage change from baseline in PSA | Standard Deviation 52.989 |
| Cohort 4 - NOX66 1200mg Daily | Change in Prostate Specific Antigen (PSA) Levels | Week 24 | 64.86 Percentage change from baseline in PSA | Standard Deviation 195.334 |
| Cohort 4 - NOX66 1200mg Daily | Change in Prostate Specific Antigen (PSA) Levels | Week 12 | -310 Percentage change from baseline in PSA | Standard Deviation 73.373 |
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).
Time frame: 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
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Cohort 1 - NOX66 400mg Daily | Change of ECOG Performance Status | Week 6 | 4 (No self-care) | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Change of ECOG Performance Status | Screening | 5 (Dead) | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Change of ECOG Performance Status | Week 12 | 2 (Ambulatory; No work activity) | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Change of ECOG Performance Status | Week 12 | 4 (No self-care) | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Change of ECOG Performance Status | Screening | 0 (Fully active) | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Change of ECOG Performance Status | Week 6 | 0 (Fully active) | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Change of ECOG Performance Status | Week 24 | 2 (Ambulatory; No work activity) | 1 Participants |
| Cohort 1 - NOX66 400mg Daily | Change of ECOG Performance Status | Week 6 | 3 (Limited self-care) | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Change of ECOG Performance Status | Screening | 1 (Ambulatory; No strenuous activity) | 4 Participants |
| Cohort 1 - NOX66 400mg Daily | Change of ECOG Performance Status | Week 6 | 1 (Ambulatory; No strenuous activity) | 4 Participants |
| Cohort 1 - NOX66 400mg Daily | Change of ECOG Performance Status | Week 12 | 5 (Dead) | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Change of ECOG Performance Status | Week 6 | 2 (Ambulatory; No work activity) | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Change of ECOG Performance Status | Week 12 | 1 (Ambulatory; No strenuous activity) | 4 Participants |
| Cohort 1 - NOX66 400mg Daily | Change of ECOG Performance Status | Screening | 4 (No self-care) | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Change of ECOG Performance Status | Week 24 | 3 (Limited self-care) | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Change of ECOG Performance Status | Screening | 3 (Limited self-care) | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Change of ECOG Performance Status | Week 12 | 0 (Fully active) | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Change of ECOG Performance Status | Week 24 | 1 (Ambulatory; No strenuous activity) | 3 Participants |
| Cohort 1 - NOX66 400mg Daily | Change of ECOG Performance Status | Week 24 | 4 (No self-care) | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Change of ECOG Performance Status | Week 24 | 0 (Fully active) | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Change of ECOG Performance Status | Week 6 | 5 (Dead) | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Change of ECOG Performance Status | Screening | 2 (Ambulatory; No work activity) | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Change of ECOG Performance Status | Week 24 | 5 (Dead) | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Change of ECOG Performance Status | Week 12 | 3 (Limited self-care) | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Change of ECOG Performance Status | Week 12 | 5 (Dead) | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Change of ECOG Performance Status | Screening | 3 (Limited self-care) | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Change of ECOG Performance Status | Week 24 | 0 (Fully active) | 2 Participants |
| Cohort 2 - NOX66 800mg Daily | Change of ECOG Performance Status | Week 24 | 1 (Ambulatory; No strenuous activity) | 1 Participants |
| Cohort 2 - NOX66 800mg Daily | Change of ECOG Performance Status | Week 24 | 2 (Ambulatory; No work activity) | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Change of ECOG Performance Status | Week 24 | 3 (Limited self-care) | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Change of ECOG Performance Status | Screening | 4 (No self-care) | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Change of ECOG Performance Status | Week 24 | 4 (No self-care) | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Change of ECOG Performance Status | Week 24 | 5 (Dead) | 1 Participants |
| Cohort 2 - NOX66 800mg Daily | Change of ECOG Performance Status | Screening | 5 (Dead) | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Change of ECOG Performance Status | Week 6 | 0 (Fully active) | 1 Participants |
| Cohort 2 - NOX66 800mg Daily | Change of ECOG Performance Status | Week 6 | 1 (Ambulatory; No strenuous activity) | 3 Participants |
| Cohort 2 - NOX66 800mg Daily | Change of ECOG Performance Status | Screening | 1 (Ambulatory; No strenuous activity) | 6 Participants |
| Cohort 2 - NOX66 800mg Daily | Change of ECOG Performance Status | Week 6 | 2 (Ambulatory; No work activity) | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Change of ECOG Performance Status | Week 6 | 3 (Limited self-care) | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Change of ECOG Performance Status | Week 6 | 4 (No self-care) | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Change of ECOG Performance Status | Week 6 | 5 (Dead) | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Change of ECOG Performance Status | Screening | 2 (Ambulatory; No work activity) | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Change of ECOG Performance Status | Week 12 | 0 (Fully active) | 2 Participants |
| Cohort 2 - NOX66 800mg Daily | Change of ECOG Performance Status | Week 12 | 1 (Ambulatory; No strenuous activity) | 1 Participants |
| Cohort 2 - NOX66 800mg Daily | Change of ECOG Performance Status | Screening | 0 (Fully active) | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Change of ECOG Performance Status | Week 12 | 2 (Ambulatory; No work activity) | 1 Participants |
| Cohort 2 - NOX66 800mg Daily | Change of ECOG Performance Status | Week 12 | 4 (No self-care) | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Change of ECOG Performance Status | Week 12 | 3 (Limited self-care) | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Change of ECOG Performance Status | Screening | 4 (No self-care) | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Change of ECOG Performance Status | Week 24 | 4 (No self-care) | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Change of ECOG Performance Status | Week 24 | 0 (Fully active) | 2 Participants |
| Cohort 3 - NOX66 1200mg Daily | Change of ECOG Performance Status | Week 6 | 5 (Dead) | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Change of ECOG Performance Status | Week 24 | 1 (Ambulatory; No strenuous activity) | 1 Participants |
| Cohort 3 - NOX66 1200mg Daily | Change of ECOG Performance Status | Week 24 | 3 (Limited self-care) | 1 Participants |
| Cohort 3 - NOX66 1200mg Daily | Change of ECOG Performance Status | Week 12 | 5 (Dead) | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Change of ECOG Performance Status | Week 12 | 0 (Fully active) | 2 Participants |
| Cohort 3 - NOX66 1200mg Daily | Change of ECOG Performance Status | Screening | 2 (Ambulatory; No work activity) | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Change of ECOG Performance Status | Week 24 | 2 (Ambulatory; No work activity) | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Change of ECOG Performance Status | Week 12 | 3 (Limited self-care) | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Change of ECOG Performance Status | Week 12 | 1 (Ambulatory; No strenuous activity) | 1 Participants |
| Cohort 3 - NOX66 1200mg Daily | Change of ECOG Performance Status | Week 12 | 4 (No self-care) | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Change of ECOG Performance Status | Week 6 | 1 (Ambulatory; No strenuous activity) | 1 Participants |
| Cohort 3 - NOX66 1200mg Daily | Change of ECOG Performance Status | Week 24 | 5 (Dead) | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Change of ECOG Performance Status | Week 6 | 2 (Ambulatory; No work activity) | 1 Participants |
| Cohort 3 - NOX66 1200mg Daily | Change of ECOG Performance Status | Screening | 1 (Ambulatory; No strenuous activity) | 2 Participants |
| Cohort 3 - NOX66 1200mg Daily | Change of ECOG Performance Status | Week 6 | 0 (Fully active) | 2 Participants |
| Cohort 3 - NOX66 1200mg Daily | Change of ECOG Performance Status | Screening | 3 (Limited self-care) | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Change of ECOG Performance Status | Week 6 | 3 (Limited self-care) | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Change of ECOG Performance Status | Screening | 5 (Dead) | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Change of ECOG Performance Status | Screening | 0 (Fully active) | 2 Participants |
| Cohort 3 - NOX66 1200mg Daily | Change of ECOG Performance Status | Week 12 | 2 (Ambulatory; No work activity) | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Change of ECOG Performance Status | Week 6 | 4 (No self-care) | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Change of ECOG Performance Status | Week 12 | 1 (Ambulatory; No strenuous activity) | 5 Participants |
| Cohort 4 - NOX66 1200mg Daily | Change of ECOG Performance Status | Screening | 0 (Fully active) | 2 Participants |
| Cohort 4 - NOX66 1200mg Daily | Change of ECOG Performance Status | Week 12 | 3 (Limited self-care) | 1 Participants |
| Cohort 4 - NOX66 1200mg Daily | Change of ECOG Performance Status | Week 24 | 5 (Dead) | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Change of ECOG Performance Status | Screening | 1 (Ambulatory; No strenuous activity) | 9 Participants |
| Cohort 4 - NOX66 1200mg Daily | Change of ECOG Performance Status | Screening | 2 (Ambulatory; No work activity) | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Change of ECOG Performance Status | Screening | 3 (Limited self-care) | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Change of ECOG Performance Status | Screening | 4 (No self-care) | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Change of ECOG Performance Status | Screening | 5 (Dead) | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Change of ECOG Performance Status | Week 6 | 0 (Fully active) | 1 Participants |
| Cohort 4 - NOX66 1200mg Daily | Change of ECOG Performance Status | Week 6 | 1 (Ambulatory; No strenuous activity) | 7 Participants |
| Cohort 4 - NOX66 1200mg Daily | Change of ECOG Performance Status | Week 6 | 2 (Ambulatory; No work activity) | 3 Participants |
| Cohort 4 - NOX66 1200mg Daily | Change of ECOG Performance Status | Week 6 | 3 (Limited self-care) | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Change of ECOG Performance Status | Week 6 | 4 (No self-care) | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Change of ECOG Performance Status | Week 6 | 5 (Dead) | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Change of ECOG Performance Status | Week 12 | 0 (Fully active) | 2 Participants |
| Cohort 4 - NOX66 1200mg Daily | Change of ECOG Performance Status | Week 12 | 2 (Ambulatory; No work activity) | 2 Participants |
| Cohort 4 - NOX66 1200mg Daily | Change of ECOG Performance Status | Week 12 | 4 (No self-care) | 1 Participants |
| Cohort 4 - NOX66 1200mg Daily | Change of ECOG Performance Status | Week 12 | 5 (Dead) | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Change of ECOG Performance Status | Week 24 | 0 (Fully active) | 2 Participants |
| Cohort 4 - NOX66 1200mg Daily | Change of ECOG Performance Status | Week 24 | 1 (Ambulatory; No strenuous activity) | 1 Participants |
| Cohort 4 - NOX66 1200mg Daily | Change of ECOG Performance Status | Week 24 | 2 (Ambulatory; No work activity) | 1 Participants |
| Cohort 4 - NOX66 1200mg Daily | Change of ECOG Performance Status | Week 24 | 3 (Limited self-care) | 1 Participants |
| Cohort 4 - NOX66 1200mg Daily | Change of ECOG Performance Status | Week 24 | 4 (No self-care) | 0 Participants |
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.
Time frame: Week 6, Week 12, and Week 24
Population: Efficacy population = all patients who completed radiation therapy with at least seven days of NOX66 treatment
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Cohort 1 - NOX66 400mg Daily | Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria | Week 6 | Not Applicable (NA) | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria | Week 12 | Not Evaluable (NE) | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria | Week 24 | Not Evaluable (NE) | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria | Week 6 | Not Evaluable (NE) | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria | Week 24 | Progressive Disease (PD) | 1 Participants |
| Cohort 1 - NOX66 400mg Daily | Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria | Week 6 | Non-CR/Non-PD | 4 Participants |
| Cohort 1 - NOX66 400mg Daily | Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria | Week 6 | Progressive Disease (PD) | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria | Week 6 | Complete Response (CR) | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria | Week 24 | Non-CR/Non-PD | 2 Participants |
| Cohort 1 - NOX66 400mg Daily | Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria | Week 24 | Complete Response (CR) | 1 Participants |
| Cohort 1 - NOX66 400mg Daily | Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria | Week 24 | Not Applicable (NA) | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria | Week 12 | Not Applicable (NA) | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria | Week 12 | Non-CR/Non-PD | 4 Participants |
| Cohort 1 - NOX66 400mg Daily | Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria | Week 12 | Complete Response (CR) | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria | Week 12 | Progressive Disease (PD) | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria | Week 24 | Not Applicable (NA) | 1 Participants |
| Cohort 2 - NOX66 800mg Daily | Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria | Week 6 | Complete Response (CR) | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria | Week 6 | Progressive Disease (PD) | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria | Week 6 | Not Applicable (NA) | 1 Participants |
| Cohort 2 - NOX66 800mg Daily | Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria | Week 12 | Not Evaluable (NE) | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria | Week 24 | Not Evaluable (NE) | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria | Week 6 | Non-CR/Non-PD | 5 Participants |
| Cohort 2 - NOX66 800mg Daily | Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria | Week 6 | Not Evaluable (NE) | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria | Week 12 | Complete Response (CR) | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria | Week 12 | Non-CR/Non-PD | 4 Participants |
| Cohort 2 - NOX66 800mg Daily | Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria | Week 12 | Progressive Disease (PD) | 1 Participants |
| Cohort 2 - NOX66 800mg Daily | Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria | Week 12 | Not Applicable (NA) | 1 Participants |
| Cohort 2 - NOX66 800mg Daily | Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria | Week 24 | Complete Response (CR) | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria | Week 24 | Non-CR/Non-PD | 4 Participants |
| Cohort 2 - NOX66 800mg Daily | Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria | Week 24 | Progressive Disease (PD) | 1 Participants |
| Cohort 3 - NOX66 1200mg Daily | Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria | Week 6 | Complete Response (CR) | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria | Week 24 | Complete Response (CR) | 1 Participants |
| Cohort 3 - NOX66 1200mg Daily | Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria | Week 12 | Progressive Disease (PD) | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria | Week 6 | Progressive Disease (PD) | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria | Week 12 | Complete Response (CR) | 1 Participants |
| Cohort 3 - NOX66 1200mg Daily | Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria | Week 24 | Non-CR/Non-PD | 2 Participants |
| Cohort 3 - NOX66 1200mg Daily | Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria | Week 24 | Not Applicable (NA) | 1 Participants |
| Cohort 3 - NOX66 1200mg Daily | Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria | Week 6 | Not Applicable (NA) | 1 Participants |
| Cohort 3 - NOX66 1200mg Daily | Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria | Week 24 | Not Evaluable (NE) | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria | Week 6 | Non-CR/Non-PD | 3 Participants |
| Cohort 3 - NOX66 1200mg Daily | Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria | Week 12 | Not Evaluable (NE) | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria | Week 12 | Not Applicable (NA) | 1 Participants |
| Cohort 3 - NOX66 1200mg Daily | Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria | Week 6 | Not Evaluable (NE) | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria | Week 24 | Progressive Disease (PD) | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria | Week 12 | Non-CR/Non-PD | 2 Participants |
| Cohort 4 - NOX66 1200mg Daily | Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria | Week 12 | Progressive Disease (PD) | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria | Week 12 | Non-CR/Non-PD | 7 Participants |
| Cohort 4 - NOX66 1200mg Daily | Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria | Week 12 | Complete Response (CR) | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria | Week 24 | Progressive Disease (PD) | 1 Participants |
| Cohort 4 - NOX66 1200mg Daily | Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria | Week 12 | Not Evaluable (NE) | 4 Participants |
| Cohort 4 - NOX66 1200mg Daily | Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria | Week 12 | Not Applicable (NA) | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria | Week 6 | Progressive Disease (PD) | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria | Week 24 | Not Evaluable (NE) | 3 Participants |
| Cohort 4 - NOX66 1200mg Daily | Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria | Week 24 | Complete Response (CR) | 1 Participants |
| Cohort 4 - NOX66 1200mg Daily | Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria | Week 6 | Complete Response (CR) | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria | Week 24 | Not Applicable (NA) | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria | Week 24 | Non-CR/Non-PD | 6 Participants |
| Cohort 4 - NOX66 1200mg Daily | Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria | Week 6 | Non-CR/Non-PD | 7 Participants |
| Cohort 4 - NOX66 1200mg Daily | Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria | Week 6 | Not Evaluable (NE) | 4 Participants |
| Cohort 4 - NOX66 1200mg Daily | Change of Non-Target Lesions in Participants According to RECIST 1.1 Criteria | Week 6 | Not Applicable (NA) | 0 Participants |
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.
Time frame: Week 6, Week 12, and Week 24
Population: Efficacy population = all patients who completed radiation therapy with at least seven days of NOX66 treatment
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Cohort 1 - NOX66 400mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 24 | Complete Response (CR) | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 6 | Progressive Disease (PD) | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 24 | Partial Response (PR) | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 24 | Stable Disease (SD) | 3 Participants |
| Cohort 1 - NOX66 400mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 24 | Not Evaluable (NE) | 1 Participants |
| Cohort 1 - NOX66 400mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 24 | Not Applicable (NA) | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 24 | Progressive Disease (PD) | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 6 | Complete Response (CR) | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 6 | Partial Response (PR) | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 6 | Stable Disease (SD) | 4 Participants |
| Cohort 1 - NOX66 400mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 6 | Not Evaluable (NE) | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 12 | Partial Response (PR) | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 6 | Not Applicable (NA) | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 12 | Complete Response (CR) | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 12 | Stable Disease (SD) | 4 Participants |
| Cohort 1 - NOX66 400mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 12 | Progressive Disease (PD) | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 12 | Not Evaluable (NE) | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 12 | Not Applicable (NA) | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 12 | Not Applicable (NA) | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 6 | Partial Response (PR) | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 12 | Complete Response (CR) | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 24 | Complete Response (CR) | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 24 | Partial Response (PR) | 1 Participants |
| Cohort 2 - NOX66 800mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 6 | Progressive Disease (PD) | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 6 | Not Evaluable (NE) | 2 Participants |
| Cohort 2 - NOX66 800mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 24 | Progressive Disease (PD) | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 6 | Complete Response (CR) | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 24 | Stable Disease (SD) | 2 Participants |
| Cohort 2 - NOX66 800mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 12 | Progressive Disease (PD) | 1 Participants |
| Cohort 2 - NOX66 800mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 24 | Not Evaluable (NE) | 3 Participants |
| Cohort 2 - NOX66 800mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 12 | Stable Disease (SD) | 2 Participants |
| Cohort 2 - NOX66 800mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 6 | Not Applicable (NA) | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 12 | Not Evaluable (NE) | 2 Participants |
| Cohort 2 - NOX66 800mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 24 | Not Applicable (NA) | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 6 | Stable Disease (SD) | 4 Participants |
| Cohort 2 - NOX66 800mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 12 | Partial Response (PR) | 1 Participants |
| Cohort 3 - NOX66 1200mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 6 | Partial Response (PR) | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 6 | Progressive Disease (PD) | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 12 | Stable Disease (SD) | 3 Participants |
| Cohort 3 - NOX66 1200mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 12 | Not Evaluable (NE) | 1 Participants |
| Cohort 3 - NOX66 1200mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 6 | Stable Disease (SD) | 4 Participants |
| Cohort 3 - NOX66 1200mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 6 | Not Evaluable (NE) | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 12 | Progressive Disease (PD) | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 6 | Not Applicable (NA) | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 24 | Complete Response (CR) | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 12 | Complete Response (CR) | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 24 | Partial Response (PR) | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 6 | Complete Response (CR) | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 24 | Progressive Disease (PD) | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 12 | Partial Response (PR) | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 24 | Not Evaluable (NE) | 1 Participants |
| Cohort 3 - NOX66 1200mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 24 | Stable Disease (SD) | 3 Participants |
| Cohort 3 - NOX66 1200mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 24 | Not Applicable (NA) | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 12 | Not Applicable (NA) | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 24 | Not Applicable (NA) | 2 Participants |
| Cohort 4 - NOX66 1200mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 6 | Progressive Disease (PD) | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 12 | Progressive Disease (PD) | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 24 | Partial Response (PR) | 1 Participants |
| Cohort 4 - NOX66 1200mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 6 | Complete Response (CR) | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 6 | Partial Response (PR) | 1 Participants |
| Cohort 4 - NOX66 1200mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 6 | Stable Disease (SD) | 8 Participants |
| Cohort 4 - NOX66 1200mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 6 | Not Evaluable (NE) | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 6 | Not Applicable (NA) | 2 Participants |
| Cohort 4 - NOX66 1200mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 12 | Complete Response (CR) | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 12 | Partial Response (PR) | 2 Participants |
| Cohort 4 - NOX66 1200mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 12 | Stable Disease (SD) | 5 Participants |
| Cohort 4 - NOX66 1200mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 12 | Not Evaluable (NE) | 2 Participants |
| Cohort 4 - NOX66 1200mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 12 | Not Applicable (NA) | 2 Participants |
| Cohort 4 - NOX66 1200mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 24 | Complete Response (CR) | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 24 | Stable Disease (SD) | 2 Participants |
| Cohort 4 - NOX66 1200mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 24 | Progressive Disease (PD) | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Change of Target Lesions in Participants According to RECIST 1.1 Criteria | Week 24 | Not Evaluable (NE) | 6 Participants |
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)
Time frame: 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
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Cohort 1 - NOX66 400mg Daily | Overall Response According to RECIST 1.1 Criteria | Week 12 | Not Evaluable (NE) | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Overall Response According to RECIST 1.1 Criteria | Week 12 | Partial Response (PR) | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Overall Response According to RECIST 1.1 Criteria | Week 12 | Stable Disease (SD) | 3 Participants |
| Cohort 1 - NOX66 400mg Daily | Overall Response According to RECIST 1.1 Criteria | Week 12 | Progressive Disease (PD) | 1 Participants |
| Cohort 1 - NOX66 400mg Daily | Overall Response According to RECIST 1.1 Criteria | Week 24 | Stable Disease (SD) | 2 Participants |
| Cohort 1 - NOX66 400mg Daily | Overall Response According to RECIST 1.1 Criteria | Week 24 | Not Evaluable (NE) | 1 Participants |
| Cohort 1 - NOX66 400mg Daily | Overall Response According to RECIST 1.1 Criteria | Week 6 | Complete Response (CR) | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Overall Response According to RECIST 1.1 Criteria | Week 12 | Complete Response (CR) | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Overall Response According to RECIST 1.1 Criteria | Week 6 | Partial Response (PR) | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Overall Response According to RECIST 1.1 Criteria | Week 6 | Stable Disease (SD) | 4 Participants |
| Cohort 1 - NOX66 400mg Daily | Overall Response According to RECIST 1.1 Criteria | Week 24 | Progressive Disease (PD) | 1 Participants |
| Cohort 1 - NOX66 400mg Daily | Overall Response According to RECIST 1.1 Criteria | Week 24 | Complete Response (CR) | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Overall Response According to RECIST 1.1 Criteria | Week 6 | Progressive Disease (PD) | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Overall Response According to RECIST 1.1 Criteria | Week 24 | Partial Response (PR) | 0 Participants |
| Cohort 1 - NOX66 400mg Daily | Overall Response According to RECIST 1.1 Criteria | Week 6 | Not Evaluable (NE) | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Overall Response According to RECIST 1.1 Criteria | Week 12 | Not Evaluable (NE) | 2 Participants |
| Cohort 2 - NOX66 800mg Daily | Overall Response According to RECIST 1.1 Criteria | Week 24 | Complete Response (CR) | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Overall Response According to RECIST 1.1 Criteria | Week 12 | Partial Response (PR) | 1 Participants |
| Cohort 2 - NOX66 800mg Daily | Overall Response According to RECIST 1.1 Criteria | Week 24 | Not Evaluable (NE) | 3 Participants |
| Cohort 2 - NOX66 800mg Daily | Overall Response According to RECIST 1.1 Criteria | Week 12 | Progressive Disease (PD) | 1 Participants |
| Cohort 2 - NOX66 800mg Daily | Overall Response According to RECIST 1.1 Criteria | Week 24 | Partial Response (PR) | 1 Participants |
| Cohort 2 - NOX66 800mg Daily | Overall Response According to RECIST 1.1 Criteria | Week 12 | Stable Disease (SD) | 2 Participants |
| Cohort 2 - NOX66 800mg Daily | Overall Response According to RECIST 1.1 Criteria | Week 24 | Stable Disease (SD) | 2 Participants |
| Cohort 2 - NOX66 800mg Daily | Overall Response According to RECIST 1.1 Criteria | Week 6 | Partial Response (PR) | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Overall Response According to RECIST 1.1 Criteria | Week 6 | Progressive Disease (PD) | 1 Participants |
| Cohort 2 - NOX66 800mg Daily | Overall Response According to RECIST 1.1 Criteria | Week 24 | Progressive Disease (PD) | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Overall Response According to RECIST 1.1 Criteria | Week 6 | Not Evaluable (NE) | 2 Participants |
| Cohort 2 - NOX66 800mg Daily | Overall Response According to RECIST 1.1 Criteria | Week 6 | Stable Disease (SD) | 3 Participants |
| Cohort 2 - NOX66 800mg Daily | Overall Response According to RECIST 1.1 Criteria | Week 12 | Complete Response (CR) | 0 Participants |
| Cohort 2 - NOX66 800mg Daily | Overall Response According to RECIST 1.1 Criteria | Week 6 | Complete Response (CR) | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Overall Response According to RECIST 1.1 Criteria | Week 24 | Partial Response (PR) | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Overall Response According to RECIST 1.1 Criteria | Week 6 | Partial Response (PR) | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Overall Response According to RECIST 1.1 Criteria | Week 6 | Not Evaluable (NE) | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Overall Response According to RECIST 1.1 Criteria | Week 6 | Complete Response (CR) | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Overall Response According to RECIST 1.1 Criteria | Week 6 | Stable Disease (SD) | 4 Participants |
| Cohort 3 - NOX66 1200mg Daily | Overall Response According to RECIST 1.1 Criteria | Week 6 | Progressive Disease (PD) | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Overall Response According to RECIST 1.1 Criteria | Week 12 | Complete Response (CR) | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Overall Response According to RECIST 1.1 Criteria | Week 12 | Partial Response (PR) | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Overall Response According to RECIST 1.1 Criteria | Week 12 | Stable Disease (SD) | 3 Participants |
| Cohort 3 - NOX66 1200mg Daily | Overall Response According to RECIST 1.1 Criteria | Week 12 | Progressive Disease (PD) | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Overall Response According to RECIST 1.1 Criteria | Week 12 | Not Evaluable (NE) | 1 Participants |
| Cohort 3 - NOX66 1200mg Daily | Overall Response According to RECIST 1.1 Criteria | Week 24 | Complete Response (CR) | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Overall Response According to RECIST 1.1 Criteria | Week 24 | Stable Disease (SD) | 3 Participants |
| Cohort 3 - NOX66 1200mg Daily | Overall Response According to RECIST 1.1 Criteria | Week 24 | Progressive Disease (PD) | 0 Participants |
| Cohort 3 - NOX66 1200mg Daily | Overall Response According to RECIST 1.1 Criteria | Week 24 | Not Evaluable (NE) | 1 Participants |
| Cohort 4 - NOX66 1200mg Daily | Overall Response According to RECIST 1.1 Criteria | Week 24 | Progressive Disease (PD) | 3 Participants |
| Cohort 4 - NOX66 1200mg Daily | Overall Response According to RECIST 1.1 Criteria | Week 12 | Not Evaluable (NE) | 3 Participants |
| Cohort 4 - NOX66 1200mg Daily | Overall Response According to RECIST 1.1 Criteria | Week 6 | Stable Disease (SD) | 9 Participants |
| Cohort 4 - NOX66 1200mg Daily | Overall Response According to RECIST 1.1 Criteria | Week 6 | Complete Response (CR) | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Overall Response According to RECIST 1.1 Criteria | Week 6 | Not Evaluable (NE) | 1 Participants |
| Cohort 4 - NOX66 1200mg Daily | Overall Response According to RECIST 1.1 Criteria | Week 24 | Partial Response (PR) | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Overall Response According to RECIST 1.1 Criteria | Week 6 | Partial Response (PR) | 1 Participants |
| Cohort 4 - NOX66 1200mg Daily | Overall Response According to RECIST 1.1 Criteria | Week 24 | Stable Disease (SD) | 2 Participants |
| Cohort 4 - NOX66 1200mg Daily | Overall Response According to RECIST 1.1 Criteria | Week 24 | Complete Response (CR) | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Overall Response According to RECIST 1.1 Criteria | Week 12 | Stable Disease (SD) | 6 Participants |
| Cohort 4 - NOX66 1200mg Daily | Overall Response According to RECIST 1.1 Criteria | Week 12 | Partial Response (PR) | 2 Participants |
| Cohort 4 - NOX66 1200mg Daily | Overall Response According to RECIST 1.1 Criteria | Week 24 | Not Evaluable (NE) | 6 Participants |
| Cohort 4 - NOX66 1200mg Daily | Overall Response According to RECIST 1.1 Criteria | Week 12 | Progressive Disease (PD) | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Overall Response According to RECIST 1.1 Criteria | Week 12 | Complete Response (CR) | 0 Participants |
| Cohort 4 - NOX66 1200mg Daily | Overall Response According to RECIST 1.1 Criteria | Week 6 | Progressive Disease (PD) | 0 Participants |