Trial Outcomes & Findings for Pembrolizumab in Patients With Leptomeningeal Disease (NCT NCT03091478)
NCT ID: NCT03091478
Last Updated: 2021-01-26
Results Overview
Eligible patients who receive at least one dose of pembrolizumab.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
At 12 weeks
Results posted on
2021-01-26
Participant Flow
Participant milestones
| Measure |
Pembrolizumab 200 mg
Pembrolizumab 200 mg every 3 weeks
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pembrolizumab in Patients With Leptomeningeal Disease
Baseline characteristics by cohort
| Measure |
Pembrolizumab 200 mg
n=13 Participants
Pembrolizumab 200 mg every 3 weeks
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=39 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: At 12 weeksEligible patients who receive at least one dose of pembrolizumab.
Outcome measures
| Measure |
Pembrolizumab 200 mg
n=13 Participants
Pembrolizumab 200 mg every 3 weeks
|
|---|---|
|
Number of Participants With a Response
Complete Response
|
2 Participants
|
|
Number of Participants With a Response
Partial Response
|
1 Participants
|
|
Number of Participants With a Response
Stable Disease
|
2 Participants
|
|
Number of Participants With a Response
Progressive Disease
|
8 Participants
|
SECONDARY outcome
Timeframe: From the date of study entry until date of death from any cause, assessed up to 24 monthsTo determine whether pembrolizumab administered in patients with Leptomeningeal disease (LMD) from solid tumors improves central nervous system (CNS) progression-free survival (PFS).
Outcome measures
| Measure |
Pembrolizumab 200 mg
n=13 Participants
Pembrolizumab 200 mg every 3 weeks
|
|---|---|
|
CNS Progression-free Survival in Patients With LMD From Solid Tumors Receiving Pembrolizumab
|
2.9 Months
Interval 1.3 to
The upper bound of the confidence interval was not reached.
|
SECONDARY outcome
Timeframe: From the date of study entry until date of death from any cause, assessed up to 24 monthsTo determine whether pembrolizumab administered in patients with LMD from solid tumors improves overall survival (OS).
Outcome measures
| Measure |
Pembrolizumab 200 mg
n=13 Participants
Pembrolizumab 200 mg every 3 weeks
|
|---|---|
|
Overall Survival in Patients With LMD From Solid Tumors Receiving Pembrolizumab
|
4.9 Months
Interval 3.7 to
The upper bound of the confidence interval was not reached.
|
Adverse Events
Pembrolizumab 200 mg
Serious events: 7 serious events
Other events: 13 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Pembrolizumab 200 mg
n=13 participants at risk
Pembrolizumab 200 mg every 3 weeks
Pembrolizumab: 200mg every 3 weeks
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
7.7%
1/13 • Number of events 1 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.4%
2/13 • Number of events 3 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
7.7%
1/13 • Number of events 1 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
15.4%
2/13 • Number of events 2 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness, Lower Limb
|
7.7%
1/13 • Number of events 1 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Nervous system disorders
Paresthesia
|
7.7%
1/13 • Number of events 1 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Psychiatric disorders
Confusion
|
15.4%
2/13 • Number of events 2 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Renal and urinary disorders
Urinary Tract Obstruction
|
7.7%
1/13 • Number of events 1 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Reproductive system and breast disorders
Pelvic Pain
|
7.7%
1/13 • Number of events 1 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Vascular disorders
Thrombolic Event- PE
|
7.7%
1/13 • Number of events 1 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
Other adverse events
| Measure |
Pembrolizumab 200 mg
n=13 participants at risk
Pembrolizumab 200 mg every 3 weeks
Pembrolizumab: 200mg every 3 weeks
|
|---|---|
|
Nervous system disorders
Tremor
|
7.7%
1/13 • Number of events 1 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Psychiatric disorders
Delusions
|
7.7%
1/13 • Number of events 1 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Psychiatric disorders
Insomnia
|
7.7%
1/13 • Number of events 1 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Renal and urinary disorders
Urinary Incontinence
|
15.4%
2/13 • Number of events 2 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Renal and urinary disorders
Urinary Retention
|
7.7%
1/13 • Number of events 1 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
46.2%
6/13 • Number of events 6 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.7%
1/13 • Number of events 1 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
7.7%
1/13 • Number of events 1 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
7.7%
1/13 • Number of events 1 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
7.7%
1/13 • Number of events 2 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
7.7%
1/13 • Number of events 1 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
23.1%
3/13 • Number of events 4 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
General disorders
Minimal Redness at site of LP
|
7.7%
1/13 • Number of events 1 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Skin and subcutaneous tissue disorders
Left cheek lesion
|
7.7%
1/13 • Number of events 1 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
38.5%
5/13 • Number of events 8 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
15.4%
2/13 • Number of events 6 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Vascular disorders
Hypotension
|
7.7%
1/13 • Number of events 1 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Surgical and medical procedures
Left supine craniotomy
|
7.7%
1/13 • Number of events 1 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Nervous system disorders
Confusion
|
15.4%
2/13 • Number of events 3 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Nervous system disorders
Dysarthria
|
7.7%
1/13 • Number of events 1 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Gastrointestinal disorders
Vomitting
|
7.7%
1/13 • Number of events 2 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.7%
1/13 • Number of events 1 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Endocrine disorders
Hypothyroidism
|
7.7%
1/13 • Number of events 1 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Eye disorders
Anisocoria
|
7.7%
1/13 • Number of events 1 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Eye disorders
Blurred Vision
|
7.7%
1/13 • Number of events 2 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Eye disorders
Dry Eye
|
7.7%
1/13 • Number of events 1 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Eye disorders
Twitching Eyelid
|
7.7%
1/13 • Number of events 1 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Gastrointestinal disorders
Abdominal Pain
|
7.7%
1/13 • Number of events 1 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Gastrointestinal disorders
Constipation
|
23.1%
3/13 • Number of events 5 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Gastrointestinal disorders
Diarrhea
|
15.4%
2/13 • Number of events 2 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Gastrointestinal disorders
Dry Mouth
|
15.4%
2/13 • Number of events 2 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.7%
1/13 • Number of events 1 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Gastrointestinal disorders
Dysphagia
|
7.7%
1/13 • Number of events 2 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Gastrointestinal disorders
Nausea
|
38.5%
5/13 • Number of events 7 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
General disorders
Face Edema
|
7.7%
1/13 • Number of events 1 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
General disorders
Edema Limbs
|
23.1%
3/13 • Number of events 3 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
General disorders
Fatigue
|
46.2%
6/13 • Number of events 10 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
General disorders
Fever
|
7.7%
1/13 • Number of events 1 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
General disorders
Infusion Related Reaction
|
7.7%
1/13 • Number of events 1 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
General disorders
Non-cardiac Chest Pain
|
7.7%
1/13 • Number of events 1 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Renal and urinary disorders
Urinary Tract Infection
|
15.4%
2/13 • Number of events 2 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Investigations
Creatinine Increased
|
7.7%
1/13 • Number of events 1 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Investigations
Weight Loss
|
15.4%
2/13 • Number of events 2 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Metabolism and nutrition disorders
Anorexia
|
23.1%
3/13 • Number of events 5 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Metabolism and nutrition disorders
Dehydration
|
7.7%
1/13 • Number of events 6 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
23.1%
3/13 • Number of events 3 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
23.1%
3/13 • Number of events 4 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
30.8%
4/13 • Number of events 7 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
15.4%
2/13 • Number of events 3 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Musculoskeletal and connective tissue disorders
Muscle Twitching
|
7.7%
1/13 • Number of events 1 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.7%
1/13 • Number of events 1 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
15.4%
2/13 • Number of events 3 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
38.5%
5/13 • Number of events 16 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Precancerious Cells from Scalp
|
7.7%
1/13 • Number of events 1 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Nervous system disorders
Ataxia
|
15.4%
2/13 • Number of events 2 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Nervous system disorders
Cerebrospinal fuild leakage
|
7.7%
1/13 • Number of events 1 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Nervous system disorders
Cognitive Disturbance
|
7.7%
1/13 • Number of events 1 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Nervous system disorders
Concentration Impairment
|
7.7%
1/13 • Number of events 3 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Nervous system disorders
Depressed level of consciousness
|
7.7%
1/13 • Number of events 1 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Nervous system disorders
Dizziness
|
7.7%
1/13 • Number of events 2 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Nervous system disorders
Dysphagia
|
7.7%
1/13 • Number of events 1 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Musculoskeletal and connective tissue disorders
Edema Cerebral
|
7.7%
1/13 • Number of events 1 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Nervous system disorders
Headache
|
38.5%
5/13 • Number of events 8 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Nervous system disorders
Lethargy
|
7.7%
1/13 • Number of events 1 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Nervous system disorders
Memory Impairment
|
15.4%
2/13 • Number of events 2 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Nervous system disorders
Paresthesia
|
15.4%
2/13 • Number of events 2 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Nervous system disorders
Peripheral Motor Neuropathy
|
7.7%
1/13 • Number of events 1 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
7.7%
1/13 • Number of events 1 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Nervous system disorders
Seizure
|
7.7%
1/13 • Number of events 1 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramping
|
7.7%
1/13 • Number of events 1 • For the time period beginning at treatment allocation/registration through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier.
|
Additional Information
Rachel Levy, MS, CCRP
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Phone: 410-502-8738
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place