Trial Outcomes & Findings for Ropidoxuridine and Whole Brain Radiation Therapy in Treating Patients With Brain Metastases (NCT NCT02993146)
NCT ID: NCT02993146
Last Updated: 2025-10-29
Results Overview
Dose limiting toxicities are protocol-defined, treatment-related adverse events.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1
Target enrollment
11 participants
Primary outcome timeframe
Up to week 8
Results posted on
2025-10-29
Participant Flow
Participant milestones
| Measure |
Dose Level 1A
Patients receive ropidoxuridine 150 mg by mouth on days 1-28 and undergo whole-brain radiotherapy (WBRT) daily, except weekends, for not more than 5 days per week beginning on day 8 for a total of 15 fractions.
|
Dose Level 1B
Patients receive ropidoxuridine 300 mg by mouth on days 1-28 and undergo whole-brain radiotherapy (WBRT) daily, except weekends, for not more than 5 days per week beginning on day 8 for a total of 15 fractions.
|
Dose Level 2A
Patients receive ropidoxuridine 1200 mg by mouth on days 1-28 and undergo whole-brain radiotherapy (WBRT) daily, except weekends, for not more than 5 days per week beginning on day 8 for a total of 15 fractions.
|
Dose Level 2B
Patients receive ropidoxuridine 1800 mg by mouth on days 1-28 and undergo whole-brain radiotherapy (WBRT) daily, except weekends, for not more than 5 days per week beginning on day 8 for a total of 15 fractions.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
7
|
2
|
|
Overall Study
COMPLETED
|
1
|
1
|
6
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Dose Level 1A
Patients receive ropidoxuridine 150 mg by mouth on days 1-28 and undergo whole-brain radiotherapy (WBRT) daily, except weekends, for not more than 5 days per week beginning on day 8 for a total of 15 fractions.
|
Dose Level 1B
Patients receive ropidoxuridine 300 mg by mouth on days 1-28 and undergo whole-brain radiotherapy (WBRT) daily, except weekends, for not more than 5 days per week beginning on day 8 for a total of 15 fractions.
|
Dose Level 2A
Patients receive ropidoxuridine 1200 mg by mouth on days 1-28 and undergo whole-brain radiotherapy (WBRT) daily, except weekends, for not more than 5 days per week beginning on day 8 for a total of 15 fractions.
|
Dose Level 2B
Patients receive ropidoxuridine 1800 mg by mouth on days 1-28 and undergo whole-brain radiotherapy (WBRT) daily, except weekends, for not more than 5 days per week beginning on day 8 for a total of 15 fractions.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
1
|
Baseline Characteristics
Ropidoxuridine and Whole Brain Radiation Therapy in Treating Patients With Brain Metastases
Baseline characteristics by cohort
| Measure |
Dose Level 1A
n=1 Participants
Patients receive ropidoxuridine 150 mg by mouth on days 1-28 and undergo whole-brain radiotherapy (WBRT) daily, except weekends, for not more than 5 days per week beginning on day 8 for a total of 15 fractions.
|
Dose Level 1B
n=1 Participants
Patients receive ropidoxuridine 300 mg by mouth on days 1-28 and undergo whole-brain radiotherapy (WBRT) daily, except weekends, for not more than 5 days per week beginning on day 8 for a total of 15 fractions.
|
Dose Level 2A
n=7 Participants
Patients receive ropidoxuridine 1200 mg by mouth on days 1-28 and undergo whole-brain radiotherapy (WBRT) daily, except weekends, for not more than 5 days per week beginning on day 8 for a total of 15 fractions.
|
Dose Level 2B
n=2 Participants
Patients receive ropidoxuridine 1800 mg by mouth on days 1-28 and undergo whole-brain radiotherapy (WBRT) daily, except weekends, for not more than 5 days per week beginning on day 8 for a total of 15 fractions.
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
48 years
n=5 Participants
|
50 years
n=7 Participants
|
60 years
n=5 Participants
|
58 years
n=4 Participants
|
58 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
7 participants
n=5 Participants
|
2 participants
n=4 Participants
|
11 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to week 8Dose limiting toxicities are protocol-defined, treatment-related adverse events.
Outcome measures
| Measure |
Dose Level 1A
n=1 Participants
Patients receive ropidoxuridine 150 mg by mouth on days 1-28 and undergo whole-brain radiotherapy (WBRT) daily, except weekends, for not more than 5 days per week beginning on day 8 for a total of 15 fractions.
|
Dose Level 1B
n=1 Participants
Patients receive ropidoxuridine 300 mg by mouth on days 1-28 and undergo whole-brain radiotherapy (WBRT) daily, except weekends, for not more than 5 days per week beginning on day 8 for a total of 15 fractions.
|
Dose Level 2A
n=6 Participants
Patients receive ropidoxuridine 1200 mg by mouth on days 1-28 and undergo whole-brain radiotherapy (WBRT) daily, except weekends, for not more than 5 days per week beginning on day 8 for a total of 15 fractions.
|
Dose Level 2B
n=1 Participants
Patients receive ropidoxuridine 1800 mg by mouth on days 1-28 and undergo whole-brain radiotherapy (WBRT) daily, except weekends, for not more than 5 days per week beginning on day 8 for a total of 15 fractions.
|
|---|---|---|---|---|
|
Number of Participants Experiencing a Dose Limiting Toxicity
Did not experience a dose limiting toxicity
|
1 Participants
|
1 Participants
|
6 Participants
|
0 Participants
|
|
Number of Participants Experiencing a Dose Limiting Toxicity
Experienced a dose limiting toxicity
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Only participants in Part 2 are included in this objective. Data was not collected for participants in Part 1 (DL 1A and 1B).
To observe and record anti-tumor activity as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Complete response is no remaining tumor. Partial response is a 30% or greater decrease in overall tumor burden. Progressive disease is a 20% or greater increase in tumor burden. Stable disease is between 20% increase and 30% decrease.
Outcome measures
| Measure |
Dose Level 1A
Patients receive ropidoxuridine 150 mg by mouth on days 1-28 and undergo whole-brain radiotherapy (WBRT) daily, except weekends, for not more than 5 days per week beginning on day 8 for a total of 15 fractions.
|
Dose Level 1B
Patients receive ropidoxuridine 300 mg by mouth on days 1-28 and undergo whole-brain radiotherapy (WBRT) daily, except weekends, for not more than 5 days per week beginning on day 8 for a total of 15 fractions.
|
Dose Level 2A
n=6 Participants
Patients receive ropidoxuridine 1200 mg by mouth on days 1-28 and undergo whole-brain radiotherapy (WBRT) daily, except weekends, for not more than 5 days per week beginning on day 8 for a total of 15 fractions.
|
Dose Level 2B
n=1 Participants
Patients receive ropidoxuridine 1800 mg by mouth on days 1-28 and undergo whole-brain radiotherapy (WBRT) daily, except weekends, for not more than 5 days per week beginning on day 8 for a total of 15 fractions.
|
|---|---|---|---|---|
|
Number of Participants With Complete Response, Partial Response, Stable Disease or Progressive Disease.
Partial Response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Complete Response, Partial Response, Stable Disease or Progressive Disease.
Stable Disease
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Complete Response, Partial Response, Stable Disease or Progressive Disease.
Progressive Disease
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Complete Response, Partial Response, Stable Disease or Progressive Disease.
Not assessed/Unknown
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Complete Response, Partial Response, Stable Disease or Progressive Disease.
Complete Response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At 6 monthsIntracranial disease status assessed at month 6.
Outcome measures
| Measure |
Dose Level 1A
n=1 Participants
Patients receive ropidoxuridine 150 mg by mouth on days 1-28 and undergo whole-brain radiotherapy (WBRT) daily, except weekends, for not more than 5 days per week beginning on day 8 for a total of 15 fractions.
|
Dose Level 1B
n=1 Participants
Patients receive ropidoxuridine 300 mg by mouth on days 1-28 and undergo whole-brain radiotherapy (WBRT) daily, except weekends, for not more than 5 days per week beginning on day 8 for a total of 15 fractions.
|
Dose Level 2A
n=6 Participants
Patients receive ropidoxuridine 1200 mg by mouth on days 1-28 and undergo whole-brain radiotherapy (WBRT) daily, except weekends, for not more than 5 days per week beginning on day 8 for a total of 15 fractions.
|
Dose Level 2B
n=1 Participants
Patients receive ropidoxuridine 1800 mg by mouth on days 1-28 and undergo whole-brain radiotherapy (WBRT) daily, except weekends, for not more than 5 days per week beginning on day 8 for a total of 15 fractions.
|
|---|---|---|---|---|
|
Intracranial Disease Status
Intracranial disease free
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Intracranial Disease Status
Intracranial disease progression
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Intracranial Disease Status
Unknown
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At Day 8Population: Collection not performed.
To establish the pharmacokinetics of daily oral dosing of IPdR for 8 days.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 28 daysTo establish safety and tolerability of oral IPdR for 28 days with whole brain radiation treatment.
Outcome measures
| Measure |
Dose Level 1A
n=1 Participants
Patients receive ropidoxuridine 150 mg by mouth on days 1-28 and undergo whole-brain radiotherapy (WBRT) daily, except weekends, for not more than 5 days per week beginning on day 8 for a total of 15 fractions.
|
Dose Level 1B
n=1 Participants
Patients receive ropidoxuridine 300 mg by mouth on days 1-28 and undergo whole-brain radiotherapy (WBRT) daily, except weekends, for not more than 5 days per week beginning on day 8 for a total of 15 fractions.
|
Dose Level 2A
n=6 Participants
Patients receive ropidoxuridine 1200 mg by mouth on days 1-28 and undergo whole-brain radiotherapy (WBRT) daily, except weekends, for not more than 5 days per week beginning on day 8 for a total of 15 fractions.
|
Dose Level 2B
n=1 Participants
Patients receive ropidoxuridine 1800 mg by mouth on days 1-28 and undergo whole-brain radiotherapy (WBRT) daily, except weekends, for not more than 5 days per week beginning on day 8 for a total of 15 fractions.
|
|---|---|---|---|---|
|
Number of Participants Experience Grade 3, 4, or 5 Adverse Events
Grade 5 adverse events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experience Grade 3, 4, or 5 Adverse Events
Grade 4 adverse events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experience Grade 3, 4, or 5 Adverse Events
Grade 3 adverse events
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants Experience Grade 3, 4, or 5 Adverse Events
Grade 1-2 adverse events
|
1 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At 6 monthsPopulation: Assessment not collected
To estimate the incidence of delayed neurological toxicity at 2, 4, and 6 months after whole blood radiation treatment.
Outcome measures
Outcome data not reported
Adverse Events
Dose Level 1A
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Dose Level 1B
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Dose Level 2A
Serious events: 2 serious events
Other events: 6 other events
Deaths: 3 deaths
Dose Level 2B
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Dose Level 1A
n=1 participants at risk
Patients receive ropidoxuridine 150 mg by mouth on days 1-28 and undergo whole-brain radiotherapy (WBRT) daily, except weekends, for not more than 5 days per week beginning on day 8 for a total of 15 fractions.
|
Dose Level 1B
n=1 participants at risk
Patients receive ropidoxuridine 300 mg by mouth on days 1-28 and undergo whole-brain radiotherapy (WBRT) daily, except weekends, for not more than 5 days per week beginning on day 8 for a total of 15 fractions.
|
Dose Level 2A
n=7 participants at risk
Patients receive ropidoxuridine 1200 mg by mouth on days 1-28 and undergo whole-brain radiotherapy (WBRT) daily, except weekends, for not more than 5 days per week beginning on day 8 for a total of 15 fractions.
|
Dose Level 2B
n=1 participants at risk
Patients receive ropidoxuridine 1800 mg by mouth on days 1-28 and undergo whole-brain radiotherapy (WBRT) daily, except weekends, for not more than 5 days per week beginning on day 8 for a total of 15 fractions.
|
|---|---|---|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/1 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
0.00%
0/7 • Up to 2 years
|
100.0%
1/1 • Up to 2 years
|
|
Psychiatric disorders
Confusion
|
0.00%
0/1 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
14.3%
1/7 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/1 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
0.00%
0/7 • Up to 2 years
|
100.0%
1/1 • Up to 2 years
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
0.00%
0/7 • Up to 2 years
|
100.0%
1/1 • Up to 2 years
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/1 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
0.00%
0/7 • Up to 2 years
|
100.0%
1/1 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Erythroderma
|
0.00%
0/1 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
0.00%
0/7 • Up to 2 years
|
100.0%
1/1 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/1 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
14.3%
1/7 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/1 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
0.00%
0/7 • Up to 2 years
|
100.0%
1/1 • Up to 2 years
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/1 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
14.3%
1/7 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Progressive disease
|
0.00%
0/1 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
14.3%
1/7 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
|
Nervous system disorders
Seizure
|
0.00%
0/1 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
14.3%
1/7 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
|
Nervous system disorders
Stroke
|
0.00%
0/1 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
14.3%
1/7 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
Other adverse events
| Measure |
Dose Level 1A
n=1 participants at risk
Patients receive ropidoxuridine 150 mg by mouth on days 1-28 and undergo whole-brain radiotherapy (WBRT) daily, except weekends, for not more than 5 days per week beginning on day 8 for a total of 15 fractions.
|
Dose Level 1B
n=1 participants at risk
Patients receive ropidoxuridine 300 mg by mouth on days 1-28 and undergo whole-brain radiotherapy (WBRT) daily, except weekends, for not more than 5 days per week beginning on day 8 for a total of 15 fractions.
|
Dose Level 2A
n=7 participants at risk
Patients receive ropidoxuridine 1200 mg by mouth on days 1-28 and undergo whole-brain radiotherapy (WBRT) daily, except weekends, for not more than 5 days per week beginning on day 8 for a total of 15 fractions.
|
Dose Level 2B
n=1 participants at risk
Patients receive ropidoxuridine 1800 mg by mouth on days 1-28 and undergo whole-brain radiotherapy (WBRT) daily, except weekends, for not more than 5 days per week beginning on day 8 for a total of 15 fractions.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
14.3%
1/7 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/1 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
28.6%
2/7 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
|
Investigations
Alkaline phosphatase increased
|
100.0%
1/1 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
14.3%
1/7 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
100.0%
1/1 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
57.1%
4/7 • Up to 2 years
|
100.0%
1/1 • Up to 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
1/1 • Up to 2 years
|
100.0%
1/1 • Up to 2 years
|
0.00%
0/7 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
|
Vascular disorders
Angioedema R lower lip
|
100.0%
1/1 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
0.00%
0/7 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
100.0%
1/1 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
57.1%
4/7 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
|
General disorders
Aphthous Ulcer
|
0.00%
0/1 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
14.3%
1/7 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/1 • Up to 2 years
|
100.0%
1/1 • Up to 2 years
|
0.00%
0/7 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
|
Eye disorders
Blurred vision
|
0.00%
0/1 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
14.3%
1/7 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
|
Gastrointestinal disorders
Constipation
|
100.0%
1/1 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
0.00%
0/7 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
100.0%
1/1 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
57.1%
4/7 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/1 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
14.3%
1/7 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
42.9%
3/7 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Dry dark skin at frontal lobe
|
100.0%
1/1 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
0.00%
0/7 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
|
Gastrointestinal disorders
Dry mouth
|
100.0%
1/1 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
42.9%
3/7 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/1 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
0.00%
0/7 • Up to 2 years
|
100.0%
1/1 • Up to 2 years
|
|
Nervous system disorders
Dysgeusia
|
100.0%
1/1 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
14.3%
1/7 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
100.0%
1/1 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
0.00%
0/7 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
|
General disorders
Edema face
|
100.0%
1/1 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
0.00%
0/7 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/1 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
0.00%
0/7 • Up to 2 years
|
100.0%
1/1 • Up to 2 years
|
|
General disorders
Fatigue
|
100.0%
1/1 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
85.7%
6/7 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
|
General disorders
Fever
|
0.00%
0/1 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
0.00%
0/7 • Up to 2 years
|
100.0%
1/1 • Up to 2 years
|
|
Eye disorders
Floaters
|
0.00%
0/1 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
14.3%
1/7 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
|
Nervous system disorders
Headache
|
100.0%
1/1 • Up to 2 years
|
100.0%
1/1 • Up to 2 years
|
71.4%
5/7 • Up to 2 years
|
100.0%
1/1 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/1 • Up to 2 years
|
100.0%
1/1 • Up to 2 years
|
0.00%
0/7 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/1 • Up to 2 years
|
100.0%
1/1 • Up to 2 years
|
0.00%
0/7 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
|
Vascular disorders
Hypertension
|
0.00%
0/1 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
14.3%
1/7 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/1 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
14.3%
1/7 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/1 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
14.3%
1/7 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
0.00%
0/7 • Up to 2 years
|
100.0%
1/1 • Up to 2 years
|
|
Investigations
Increased LDH
|
100.0%
1/1 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
0.00%
0/7 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
|
General disorders
Left Knee edema
|
100.0%
1/1 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
0.00%
0/7 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
|
Investigations
Leukopenia
|
0.00%
0/1 • Up to 2 years
|
100.0%
1/1 • Up to 2 years
|
0.00%
0/7 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/1 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
28.6%
2/7 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/1 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
28.6%
2/7 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
|
Gastrointestinal disorders
Nausea
|
100.0%
1/1 • Up to 2 years
|
100.0%
1/1 • Up to 2 years
|
71.4%
5/7 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
|
Gastrointestinal disorders
Numbs gum/less sensation
|
0.00%
0/1 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
0.00%
0/7 • Up to 2 years
|
100.0%
1/1 • Up to 2 years
|
|
Gastrointestinal disorders
Oral dysesthesia
|
0.00%
0/1 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
0.00%
0/7 • Up to 2 years
|
100.0%
1/1 • Up to 2 years
|
|
General disorders
Pain
|
100.0%
1/1 • Up to 2 years
|
100.0%
1/1 • Up to 2 years
|
0.00%
0/7 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/1 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
28.6%
2/7 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
|
Investigations
Platelet count decreased
|
0.00%
0/1 • Up to 2 years
|
100.0%
1/1 • Up to 2 years
|
0.00%
0/7 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/1 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
42.9%
3/7 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
|
Eye disorders
Scratching
|
0.00%
0/1 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
14.3%
1/7 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
|
Cardiac disorders
Sinus tachycardia
|
100.0%
1/1 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
0.00%
0/7 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/1 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
14.3%
1/7 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/1 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
14.3%
1/7 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/1 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
14.3%
1/7 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
|
Infections and infestations
Thrush
|
0.00%
0/1 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
14.3%
1/7 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
|
Nervous system disorders
Tremor
|
0.00%
0/1 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
0.00%
0/7 • Up to 2 years
|
100.0%
1/1 • Up to 2 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
28.6%
2/7 • Up to 2 years
|
100.0%
1/1 • Up to 2 years
|
|
Eye disorders
Watering eyes
|
0.00%
0/1 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
14.3%
1/7 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
|
Investigations
Weight loss
|
0.00%
0/1 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
14.3%
1/7 • Up to 2 years
|
0.00%
0/1 • Up to 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60