Trial Outcomes & Findings for Feasibility Study of Modified Atkins Ketogenic Diet in the Treatment of Newly Diagnosed Malignant Glioma (NCT NCT03278249)
NCT ID: NCT03278249
Last Updated: 2024-09-19
Results Overview
Ketosis measured by serum beta-hydroxybuterate. Ketosis is defined as having serum beta-hydroxybuterate (BHB) at \> 0.05 mM. Participants' BHB levels were assessed at 6 weeks after starting the study. The number of participants who had BHB at \> 0.05 mM were considered to have entered into ketosis. 9 of 9 participants met this criteria.
COMPLETED
NA
12 participants
6 weeks
2024-09-19
Participant Flow
Participant milestones
| Measure |
Modified Atkins Ketogenic Diet
Modified Atkins Ketogenic Diet in combination with Temodar and Radiation
Modified Atkins Ketogenic Diet: Less than 20 grams of carbohydrates per day
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Modified Atkins Ketogenic Diet
Modified Atkins Ketogenic Diet in combination with Temodar and Radiation
Modified Atkins Ketogenic Diet: Less than 20 grams of carbohydrates per day
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Feasibility Study of Modified Atkins Ketogenic Diet in the Treatment of Newly Diagnosed Malignant Glioma
Baseline characteristics by cohort
| Measure |
Modified Atkins Ketogenic Diet
n=9 Participants
Modified Atkins Ketogenic Diet in combination with Temodar and Radiation
Modified Atkins Ketogenic Diet: Less than 20 grams of carbohydrates per day
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeksKetosis measured by serum beta-hydroxybuterate. Ketosis is defined as having serum beta-hydroxybuterate (BHB) at \> 0.05 mM. Participants' BHB levels were assessed at 6 weeks after starting the study. The number of participants who had BHB at \> 0.05 mM were considered to have entered into ketosis. 9 of 9 participants met this criteria.
Outcome measures
| Measure |
Modified Atkins Ketogenic Diet
n=9 Participants
Modified Atkins Ketogenic Diet in combination with Temodar and Radiation
Modified Atkins Ketogenic Diet: Less than 20 grams of carbohydrates per day
|
|---|---|
|
Number of Participants With Ketosis
|
9 Participants
|
SECONDARY outcome
Timeframe: 6 monthsProgression Free Survival (PFS) is defined as the percentage of patients without progression at 6 months. Progression will be evaluated via Radiographic Assessment in Neuro-oncology (RANO) criteria: \>5 mm increase in maximal diameter, as well as ≥ 25% increase in the sum of the products of the progressing.
Outcome measures
| Measure |
Modified Atkins Ketogenic Diet
n=9 Participants
Modified Atkins Ketogenic Diet in combination with Temodar and Radiation
Modified Atkins Ketogenic Diet: Less than 20 grams of carbohydrates per day
|
|---|---|
|
Number of Participants With Progression Free Survival
|
6 Participants
|
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
| Measure |
Modified Atkins Ketogenic Diet
n=9 Participants
Modified Atkins Ketogenic Diet in combination with Temodar and Radiation
Modified Atkins Ketogenic Diet: Less than 20 grams of carbohydrates per day
|
|---|---|
|
Assessment of Survival
|
6 Participants
|
Adverse Events
Modified Atkins Ketogenic Diet
Serious adverse events
| Measure |
Modified Atkins Ketogenic Diet
n=9 participants at risk
Modified Atkins Ketogenic Diet in combination with Temodar and Radiation
Modified Atkins Ketogenic Diet: Less than 20 grams of carbohydrates per day
|
|---|---|
|
Nervous system disorders
Memory impairment
|
11.1%
1/9 • Number of events 1 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) - Extremity-lower
|
11.1%
1/9 • Number of events 1 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
Nervous system disorders
Hydrocephalus
|
11.1%
1/9 • Number of events 1 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
Infections and infestations
Infection with unknown ANC - Wound
|
11.1%
1/9 • Number of events 1 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
22.2%
2/9 • Number of events 2 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
Investigations
Investigations, please specify
|
11.1%
1/9 • Number of events 1 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
Investigations
Leukocytes (total WBC)
|
11.1%
1/9 • Number of events 1 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
Blood and lymphatic system disorders
Lymphatics - Other (Specify, __)
|
11.1%
1/9 • Number of events 1 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
11.1%
1/9 • Number of events 1 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
Investigations
Platelets
|
11.1%
1/9 • Number of events 2 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
11.1%
1/9 • Number of events 1 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
Other adverse events
| Measure |
Modified Atkins Ketogenic Diet
n=9 participants at risk
Modified Atkins Ketogenic Diet in combination with Temodar and Radiation
Modified Atkins Ketogenic Diet: Less than 20 grams of carbohydrates per day
|
|---|---|
|
Immune system disorders
Allergic reaction
|
11.1%
1/9 • Number of events 1 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
Metabolism and nutrition disorders
Anorexia
|
11.1%
1/9 • Number of events 2 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
Psychiatric disorders
Anxiety
|
22.2%
2/9 • Number of events 2 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
Ear and labyrinth disorders
Auditory/Ear - Other (Specify, __)
|
11.1%
1/9 • Number of events 1 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
Injury, poisoning and procedural complications
Bruising
|
22.2%
2/9 • Number of events 2 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
Nervous system disorders
Cognitive disturbance
|
11.1%
1/9 • Number of events 1 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
Gastrointestinal disorders
Constipation
|
66.7%
6/9 • Number of events 6 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
Psychiatric disorders
Depression
|
11.1%
1/9 • Number of events 1 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
3/9 • Number of events 4 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
Nervous system disorders
Dizziness
|
33.3%
3/9 • Number of events 3 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
General disorders
Edema: head and neck
|
11.1%
1/9 • Number of events 1 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
General disorders
Edema: limb
|
22.2%
2/9 • Number of events 2 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
General disorders
Fatigue
|
77.8%
7/9 • Number of events 8 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
22.2%
2/9 • Number of events 2 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
Ear and labyrinth disorders
Hearing
|
11.1%
1/9 • Number of events 1 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
11.1%
1/9 • Number of events 1 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
11.1%
1/9 • Number of events 1 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
Investigations
Hyperglycemia
|
11.1%
1/9 • Number of events 2 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
Vascular disorders
Hypertension
|
11.1%
1/9 • Number of events 1 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
Psychiatric disorders
Insomnia
|
11.1%
1/9 • Number of events 1 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
Psychiatric disorders
Irritability
|
11.1%
1/9 • Number of events 1 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
Investigations
Leukocytes (total WBC)
|
22.2%
2/9 • Number of events 6 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) - Extraocular
|
11.1%
1/9 • Number of events 1 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) - Extremity-upper
|
11.1%
1/9 • Number of events 1 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) - Facial
|
11.1%
1/9 • Number of events 1 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) - Ocular
|
11.1%
1/9 • Number of events 1 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized
|
11.1%
1/9 • Number of events 1 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
3/9 • Number of events 4 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
Nervous system disorders
Neurology - Other (Specify, __)
|
22.2%
2/9 • Number of events 3 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
Nervous system disorders
Neuropathy: sensory
|
11.1%
1/9 • Number of events 1 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
11.1%
1/9 • Number of events 3 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
Eye disorders
Ophthalmoplegia/diplopia (double vision)
|
11.1%
1/9 • Number of events 1 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
Infections and infestations
Oral cavity-gums (gingivitis)
|
11.1%
1/9 • Number of events 1 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
22.2%
2/9 • Number of events 2 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
Nervous system disorders
Pain - Head/headache
|
11.1%
1/9 • Number of events 1 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
Musculoskeletal and connective tissue disorders
Pain - Muscle
|
11.1%
1/9 • Number of events 1 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
Eye disorders
Photosensitivity
|
11.1%
1/9 • Number of events 2 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
Investigations
Platelets
|
11.1%
1/9 • Number of events 1 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
Investigations
Potassium, serum-low (hypokalemia)
|
22.2%
2/9 • Number of events 3 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
11.1%
1/9 • Number of events 1 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
11.1%
1/9 • Number of events 1 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
Skin and subcutaneous tissue disorders
Rash: dermatitis associated with radiation - Chemoradiation
|
44.4%
4/9 • Number of events 4 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
General disorders
Rigors/chills
|
11.1%
1/9 • Number of events 1 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
Nervous system disorders
Seizure
|
11.1%
1/9 • Number of events 1 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
Infections and infestations
Skin (cellulitis)
|
11.1%
1/9 • Number of events 1 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
Skin and subcutaneous tissue disorders
Skin breakdown/decubitus ulcer
|
11.1%
1/9 • Number of events 1 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
Nervous system disorders
Speech impairment (e.g., dysphasia or aphasia)
|
11.1%
1/9 • Number of events 1 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
Nervous system disorders
Syncope (fainting)
|
11.1%
1/9 • Number of events 1 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
General disorders
Syndromes - Other (Specify, __)
|
11.1%
1/9 • Number of events 1 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
11.1%
1/9 • Number of events 1 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
Nervous system disorders
Tremor
|
11.1%
1/9 • Number of events 1 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
11.1%
1/9 • Number of events 1 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
Infections and infestations
Urinary tract NOS
|
22.2%
2/9 • Number of events 2 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
Eye disorders
Vision-blurred vision
|
11.1%
1/9 • Number of events 1 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
Gastrointestinal disorders
Vomiting
|
22.2%
2/9 • Number of events 2 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
Investigations
Weight loss
|
22.2%
2/9 • Number of events 3 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
|
Injury, poisoning and procedural complications
Wound
|
11.1%
1/9 • Number of events 1 • Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
|
Additional Information
Rekha Chaudhary, MD, Adjunct-Associate Professor of Medicine
University of Cincinnati Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place