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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

12 participants

Primary outcome timeframe

6 weeks

Results posted on

2024-09-19

Participant Flow

Participant milestones

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

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

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 weeks

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.

Outcome measures

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 months

Progression 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

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 years

Outcome measures

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
Assessment of Survival
6 Participants

Adverse Events

Modified Atkins Ketogenic Diet

Serious events: 6 serious events
Other events: 9 other events
Deaths: 3 deaths

Serious adverse events

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

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

Phone: 513-558-2119

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place