Trial Outcomes & Findings for Valproic Acid With Temozolomide and Radiation Therapy to Treat Brain Tumors (NCT NCT00302159)
NCT ID: NCT00302159
Last Updated: 2016-08-18
Results Overview
Progression free survival is the interval from initiation of treatment on protocol to symptomatic or radiographic progression. Progressive disease is a \>25% increase in contrast enhancing tumor volume documented at the initiation of treatment on protocol.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
43 participants
Primary outcome timeframe
up to 51 months
Results posted on
2016-08-18
Participant Flow
Participant milestones
| Measure |
Valproic Acid
adjuvant therapy
Temozolomide Orally 75mg/m\^2 first day of radiation until completion. Restart 4 weeks post radiation.
Valproic Acid Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.
Radiation therapy External beam radiation Monday-Friday in 2 Gy fractions to 60 Gy total.
|
|---|---|
|
Overall Study
STARTED
|
43
|
|
Overall Study
COMPLETED
|
41
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Valproic Acid
adjuvant therapy
Temozolomide Orally 75mg/m\^2 first day of radiation until completion. Restart 4 weeks post radiation.
Valproic Acid Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.
Radiation therapy External beam radiation Monday-Friday in 2 Gy fractions to 60 Gy total.
|
|---|---|
|
Overall Study
pt declined before treatment started
|
1
|
|
Overall Study
pt started Avastin
|
1
|
Baseline Characteristics
Valproic Acid With Temozolomide and Radiation Therapy to Treat Brain Tumors
Baseline characteristics by cohort
| Measure |
Valproic Acid
n=43 Participants
adjuvant therapy
Temozolomide Orally 75mg/m\^2 first day of radiation until completion. Restart 4 weeks post radiation.
Valproic Acid Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.
Radiation therapy External beam radiation Monday-Friday in 2 Gy fractions to 60 Gy total.
|
|---|---|
|
Age, Continuous
|
52.88 years
STANDARD_DEVIATION 11.33 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
39 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 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
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
43 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 51 monthsProgression free survival is the interval from initiation of treatment on protocol to symptomatic or radiographic progression. Progressive disease is a \>25% increase in contrast enhancing tumor volume documented at the initiation of treatment on protocol.
Outcome measures
| Measure |
Valproic Acid
n=43 Participants
adjuvant therapy
Temozolomide Orally 75mg/m\^2 first day of radiation until completion. Restart 4 weeks post radiation.
Valproic Acid Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.
Radiation therapy External beam radiation Monday-Friday in 2 Gy fractions to 60 Gy total.
|
|---|---|
|
Median Progression Free Survival.
|
10.5 months
Interval 7.0 to 51.0
|
PRIMARY outcome
Timeframe: 6, 12, and 24 monthsPercentage of participants who were progression free by 6, 12, or 24 months. Progressive disease is a \>25% increase in contrast enhancing tumor volume documented at the initiation of treatment on protocol.
Outcome measures
| Measure |
Valproic Acid
n=43 Participants
adjuvant therapy
Temozolomide Orally 75mg/m\^2 first day of radiation until completion. Restart 4 weeks post radiation.
Valproic Acid Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.
Radiation therapy External beam radiation Monday-Friday in 2 Gy fractions to 60 Gy total.
|
|---|---|
|
Percentage of Participants With Progression Free Survival at 6, 12, and 24 Months
6 months
|
70 percentage of participants
|
|
Percentage of Participants With Progression Free Survival at 6, 12, and 24 Months
12 months
|
43 percentage of participants
|
|
Percentage of Participants With Progression Free Survival at 6, 12, and 24 Months
24 months
|
38 percentage of participants
|
PRIMARY outcome
Timeframe: up to 63.8 monthsBest response recorded from the start of treatment until disease progression/recurrence. Complete response is complete resolution of all contrast enhancing tumor documented at initiation of treatment on protocol, with no appearance of new lesions. Partial response is a \>50% reduction in the contrast enhancing tumor volume documented at the initiation of treatment on protocol. Minor response is a \>25%, but \<50% reduction in the contrast enhancing tumor volume documented at the initiation of treatment on protocol. Stable disease is a change in tumor size less than MR but not demonstrating progressive disease. Progressive disease is a \>25% increase in contrast enhancing tumor volume documented at the initiation of treatment on protocol. Not evaluable means the participant cannot be evaluated (e.g., quality of scan).
Outcome measures
| Measure |
Valproic Acid
n=43 Participants
adjuvant therapy
Temozolomide Orally 75mg/m\^2 first day of radiation until completion. Restart 4 weeks post radiation.
Valproic Acid Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.
Radiation therapy External beam radiation Monday-Friday in 2 Gy fractions to 60 Gy total.
|
|---|---|
|
Number of Participants With Best Response
Complete Response
|
0 participants
|
|
Number of Participants With Best Response
Partial Response
|
0 participants
|
|
Number of Participants With Best Response
Minor Response
|
0 participants
|
|
Number of Participants With Best Response
Stable Disease
|
27 participants
|
|
Number of Participants With Best Response
Progressive Disease
|
7 participants
|
|
Number of Participants With Best Response
Not Evaluable
|
9 participants
|
PRIMARY outcome
Timeframe: up to 63.8 monthsSurvival is the interval from the initiation of treatment on protocol to date of death.
Outcome measures
| Measure |
Valproic Acid
n=43 Participants
adjuvant therapy
Temozolomide Orally 75mg/m\^2 first day of radiation until completion. Restart 4 weeks post radiation.
Valproic Acid Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.
Radiation therapy External beam radiation Monday-Friday in 2 Gy fractions to 60 Gy total.
|
|---|---|
|
Median Overall Survival
|
29.6 months
Interval 21.0 to 63.8
|
PRIMARY outcome
Timeframe: 6, 12, and 24 monthsPercentage of participants who were alive at 6, 12, and 24 months.
Outcome measures
| Measure |
Valproic Acid
n=43 Participants
adjuvant therapy
Temozolomide Orally 75mg/m\^2 first day of radiation until completion. Restart 4 weeks post radiation.
Valproic Acid Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.
Radiation therapy External beam radiation Monday-Friday in 2 Gy fractions to 60 Gy total.
|
|---|---|
|
Percentage of Participants With Overall Survival at 6, 12, and 24 Months
6 months
|
97 percentage of participants
|
|
Percentage of Participants With Overall Survival at 6, 12, and 24 Months
12 months
|
86 percentage of participants
|
|
Percentage of Participants With Overall Survival at 6, 12, and 24 Months
24 months
|
56 percentage of participants
|
SECONDARY outcome
Timeframe: 6 years, 7 months and 27 daysHere is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.
Outcome measures
| Measure |
Valproic Acid
n=43 Participants
adjuvant therapy
Temozolomide Orally 75mg/m\^2 first day of radiation until completion. Restart 4 weeks post radiation.
Valproic Acid Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.
Radiation therapy External beam radiation Monday-Friday in 2 Gy fractions to 60 Gy total.
|
|---|---|
|
Number of Participants With Adverse Events
|
43 participants
|
Adverse Events
Valproic Acid
Serious events: 17 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Valproic Acid
n=43 participants at risk
adjuvant therapy
Temozolomide Orally 75mg/m\^2 first day of radiation until completion. Restart 4 weeks post radiation.
Valproic Acid Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.
Radiation therapy External beam radiation Monday-Friday in 2 Gy fractions to 60 Gy total.
|
|---|---|
|
Metabolism and nutrition disorders
Amylase
|
2.3%
1/43 • Number of events 1
|
|
Nervous system disorders
Ataxia (incoordination)
|
7.0%
3/43 • Number of events 3
|
|
Nervous system disorders
Confusion
|
4.7%
2/43 • Number of events 2
|
|
General disorders
Death not associated with CTCAE term::Disease progression NOS
|
2.3%
1/43 • Number of events 1
|
|
Gastrointestinal disorders
Dehydration
|
2.3%
1/43 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
2.3%
1/43 • Number of events 1
|
|
Nervous system disorders
Encephalopathy
|
2.3%
1/43 • Number of events 1
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
2.3%
1/43 • Number of events 1
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
2.3%
1/43 • Number of events 1
|
|
Nervous system disorders
Hemorrhage, CNS
|
4.7%
2/43 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.3%
1/43 • Number of events 2
|
|
Infections and infestations
Infection - Other (Specify, pneumonia)
|
2.3%
1/43 • Number of events 1
|
|
Blood and lymphatic system disorders
Lymphopenia
|
2.3%
1/43 • Number of events 1
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory - Other (Specify, high ammonia)
|
2.3%
1/43 • Number of events 1
|
|
Nervous system disorders
Mood alteration::Agitation
|
4.7%
2/43 • Number of events 2
|
|
Nervous system disorders
Neuropathy: motor
|
7.0%
3/43 • Number of events 3
|
|
Nervous system disorders
Pain::Head/headache
|
2.3%
1/43 • Number of events 1
|
|
Blood and lymphatic system disorders
Platelets
|
4.7%
2/43 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (Specify, PE)
|
2.3%
1/43 • Number of events 1
|
|
Nervous system disorders
Seizure
|
9.3%
4/43 • Number of events 4
|
|
Nervous system disorders
Speech impairment (e.g., dysphasia or aphasia)
|
4.7%
2/43 • Number of events 2
|
|
Eye disorders
Vision-blurred vision
|
2.3%
1/43 • Number of events 1
|
Other adverse events
| Measure |
Valproic Acid
n=43 participants at risk
adjuvant therapy
Temozolomide Orally 75mg/m\^2 first day of radiation until completion. Restart 4 weeks post radiation.
Valproic Acid Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.
Radiation therapy External beam radiation Monday-Friday in 2 Gy fractions to 60 Gy total.
|
|---|---|
|
Eye disorders
Nystagmus
|
4.7%
2/43 • Number of events 2
|
|
Eye disorders
Ocular/Visual - Other (Specify)
|
7.0%
3/43 • Number of events 3
|
|
Ear and labyrinth disorders
Otitis, middle ear (non-infectious)
|
2.3%
1/43 • Number of events 2
|
|
General disorders
Pain - Other (Specify,jaw; right shoulder; whole body)
|
4.7%
2/43 • Number of events 3
|
|
Gastrointestinal disorders
Pain::Abdomen NOS
|
7.0%
3/43 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Pain::Back
|
4.7%
2/43 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pain::Chest/thorax NOS
|
2.3%
1/43 • Number of events 1
|
|
Gastrointestinal disorders
Pain::Dental/teeth/peridontal
|
2.3%
1/43 • Number of events 1
|
|
Gastrointestinal disorders
Pain::Esophagus
|
2.3%
1/43 • Number of events 1
|
|
Ear and labyrinth disorders
Pain::External ear
|
2.3%
1/43 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain::Extremity-limb
|
4.7%
2/43 • Number of events 3
|
|
Nervous system disorders
Pain::Head/headache
|
32.6%
14/43 • Number of events 20
|
|
Musculoskeletal and connective tissue disorders
Pain::Joint
|
9.3%
4/43 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Pain::Muscle
|
4.7%
2/43 • Number of events 3
|
|
General disorders
Pain::Pain NOS
|
2.3%
1/43 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pain::Scalp
|
4.7%
2/43 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pain::Throat/pharynx/larynx
|
4.7%
2/43 • Number of events 2
|
|
Hepatobiliary disorders
Pancreatitis
|
4.7%
2/43 • Number of events 2
|
|
Blood and lymphatic system disorders
Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)
|
2.3%
1/43 • Number of events 1
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
4.7%
2/43 • Number of events 3
|
|
Blood and lymphatic system disorders
Platelets
|
62.8%
27/43 • Number of events 63
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
32.6%
14/43 • Number of events 26
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
4.7%
2/43 • Number of events 2
|
|
Nervous system disorders
Psychosis (hallucinations/delusions)
|
4.7%
2/43 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (Specify, pulomonary embolism)
|
2.3%
1/43 • Number of events 1
|
|
Nervous system disorders
Pyramidal tract dysfunction
|
2.3%
1/43 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
9.3%
4/43 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
4.7%
2/43 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Rash: dermatitis associated with radiation::Chemoradiation
|
9.3%
4/43 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Rash: dermatitis associated with radiation::Radiation
|
11.6%
5/43 • Number of events 6
|
|
Nervous system disorders
Seizure
|
25.6%
11/43 • Number of events 18
|
|
Metabolism and nutrition disorders
Sodium, serum-high (hypernatremia)
|
25.6%
11/43 • Number of events 16
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
25.6%
11/43 • Number of events 20
|
|
Nervous system disorders
Somnolence/depressed level of consciousness
|
14.0%
6/43 • Number of events 6
|
|
Nervous system disorders
Speech impairment (e.g., dysphasia or aphasia)
|
9.3%
4/43 • Number of events 5
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia::Sinus tachycardia
|
2.3%
1/43 • Number of events 1
|
|
General disorders
Sweating (diaphoresis)
|
2.3%
1/43 • Number of events 1
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
7.0%
3/43 • Number of events 3
|
|
Ear and labyrinth disorders
Tinnitus
|
9.3%
4/43 • Number of events 4
|
|
Nervous system disorders
Tremor
|
9.3%
4/43 • Number of events 6
|
|
Metabolism and nutrition disorders
Uric acid, serum-high (hyperuricemia)
|
14.0%
6/43 • Number of events 9
|
|
Eye disorders
Vision-blurred vision
|
9.3%
4/43 • Number of events 4
|
|
Eye disorders
Vision-flashing lights/floaters
|
2.3%
1/43 • Number of events 1
|
|
Eye disorders
Vision-photophobia
|
2.3%
1/43 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
18.6%
8/43 • Number of events 8
|
|
Eye disorders
Watery eye (epiphora, tearing)
|
4.7%
2/43 • Number of events 2
|
|
General disorders
Weight gain
|
2.3%
1/43 • Number of events 1
|
|
General disorders
Weight loss
|
4.7%
2/43 • Number of events 2
|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
34.9%
15/43 • Number of events 19
|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
14.0%
6/43 • Number of events 7
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
62.8%
27/43 • Number of events 41
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
4.7%
2/43 • Number of events 2
|
|
Immune system disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
9.3%
4/43 • Number of events 4
|
|
Metabolism and nutrition disorders
Amylase
|
14.0%
6/43 • Number of events 9
|
|
Gastrointestinal disorders
Anorexia
|
14.0%
6/43 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Arthritis (non-septic)
|
2.3%
1/43 • Number of events 1
|
|
Nervous system disorders
Ataxia (incoordination)
|
23.3%
10/43 • Number of events 15
|
|
Ear and labyrinth disorders
Auditory/Ear - Other (Specify, decreased hearing)
|
2.3%
1/43 • Number of events 1
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
16.3%
7/43 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm, wheezing
|
2.3%
1/43 • Number of events 1
|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia)
|
11.6%
5/43 • Number of events 5
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
9.3%
4/43 • Number of events 6
|
|
Cardiac disorders
Cardiac General - Other (Specify, systolic ejection murmur noted)
|
2.3%
1/43 • Number of events 1
|
|
Nervous system disorders
Cognitive disturbance
|
2.3%
1/43 • Number of events 1
|
|
Nervous system disorders
Confusion
|
37.2%
16/43 • Number of events 19
|
|
Gastrointestinal disorders
Constipation
|
39.5%
17/43 • Number of events 19
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.3%
4/43 • Number of events 4
|
|
Metabolism and nutrition disorders
Creatinine
|
11.6%
5/43 • Number of events 6
|
|
Endocrine disorders
Cushingoid appearance (e.g., moon face, buffalo hump, centripetal obesity, cutaneous striae)
|
4.7%
2/43 • Number of events 2
|
|
Gastrointestinal disorders
Dehydration
|
4.7%
2/43 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, cyst R axilla)
|
2.3%
1/43 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
4.7%
2/43 • Number of events 3
|
|
Nervous system disorders
Dizziness
|
11.6%
5/43 • Number of events 7
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
2.3%
1/43 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.3%
1/43 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
4.7%
2/43 • Number of events 2
|
|
Blood and lymphatic system disorders
Edema: head and neck
|
9.3%
4/43 • Number of events 4
|
|
Blood and lymphatic system disorders
Edema: limb
|
9.3%
4/43 • Number of events 5
|
|
Nervous system disorders
Encephalopathy
|
4.7%
2/43 • Number of events 2
|
|
Nervous system disorders
Extrapyramidal/involuntary movement/restlessness
|
4.7%
2/43 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Extremity-upper (function)
|
2.3%
1/43 • Number of events 1
|
|
Eye disorders
Eyelid dysfunction
|
2.3%
1/43 • Number of events 2
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
58.1%
25/43 • Number of events 34
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
4.7%
2/43 • Number of events 2
|
|
Gastrointestinal disorders
Flatulence
|
4.7%
2/43 • Number of events 2
|
|
Gastrointestinal disorders
Gastritis (including bile reflux gastritis)
|
2.3%
1/43 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal - Other (Specify, GERD)
|
2.3%
1/43 • Number of events 1
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
9.3%
4/43 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
53.5%
23/43 • Number of events 23
|
|
Ear and labyrinth disorders
Hearing: patients without baseline audiogram and not enrolled in a monitoring program
|
4.7%
2/43 • Number of events 2
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
2.3%
1/43 • Number of events 1
|
|
Blood and lymphatic system disorders
Hemoglobin
|
30.2%
13/43 • Number of events 23
|
|
Gastrointestinal disorders
Hemorrhage, GI::Anus
|
2.3%
1/43 • Number of events 1
|
|
Reproductive system and breast disorders
Hemorrhage, GU::Vagina
|
2.3%
1/43 • Number of events 1
|
|
Gastrointestinal disorders
Hemorrhoids
|
2.3%
1/43 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
4.7%
2/43 • Number of events 2
|
|
Vascular disorders
Hypertension
|
4.7%
2/43 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Hypopigmentation
|
2.3%
1/43 • Number of events 1
|
|
Vascular disorders
Hypotension
|
2.3%
1/43 • Number of events 1
|
|
Blood and lymphatic system disorders
INR (International Normalized Ratio of prothrombin time)
|
2.3%
1/43 • Number of events 1
|
|
Renal and urinary disorders
Incontinence, urinary
|
4.7%
2/43 • Number of events 2
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Conjunctiva
|
2.3%
1/43 • Number of events 1
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Middle ear (otitis media)
|
2.3%
1/43 • Number of events 1
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Skin (cellulitis)
|
4.7%
2/43 • Number of events 2
|
|
Infections and infestations
Infection with unknown ANC::Bronchus
|
2.3%
1/43 • Number of events 1
|
|
Infections and infestations
Infection with unknown ANC::Paranasal
|
2.3%
1/43 • Number of events 1
|
|
Infections and infestations
Infection with unknown ANC::Skin (cellulites)
|
2.3%
1/43 • Number of events 1
|
|
General disorders
Insomnia
|
16.3%
7/43 • Number of events 7
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
32.6%
14/43 • Number of events 42
|
|
Metabolism and nutrition disorders
Lipase
|
14.0%
6/43 • Number of events 10
|
|
Blood and lymphatic system disorders
Lymphatics - Other (Specify)
|
4.7%
2/43 • Number of events 3
|
|
Blood and lymphatic system disorders
Lymphopenia
|
62.8%
27/43 • Number of events 79
|
|
Metabolism and nutrition disorders
Magnesium, serum-high (hypermagnesemia)
|
34.9%
15/43 • Number of events 18
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
7.0%
3/43 • Number of events 3
|
|
Nervous system disorders
Memory impairment
|
18.6%
8/43 • Number of events 8
|
|
Nervous system disorders
Mental status
|
2.3%
1/43 • Number of events 1
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory - Other (Specify)
|
9.3%
4/43 • Number of events 6
|
|
Nervous system disorders
Mood alteration::Agitation
|
14.0%
6/43 • Number of events 7
|
|
Nervous system disorders
Mood alteration::Anxiety
|
11.6%
5/43 • Number of events 7
|
|
Nervous system disorders
Mood alteration::Depression
|
9.3%
4/43 • Number of events 4
|
|
Nervous system disorders
Mood alteration::Euphoria
|
2.3%
1/43 • Number of events 2
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam)::Oral cavity
|
4.7%
2/43 • Number of events 2
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic)::Oral cavity
|
2.3%
1/43 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy)::Extremity-upper
|
4.7%
2/43 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy)::Facial
|
2.3%
1/43 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy)::Left-sided
|
2.3%
1/43 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy)::Right-sided
|
4.7%
2/43 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other (Specify, ® rotator cuff injury)
|
2.3%
1/43 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
53.5%
23/43 • Number of events 30
|
|
Nervous system disorders
Neurology - Other (Specify)
|
11.6%
5/43 • Number of events 5
|
|
Nervous system disorders
Neuropathy: cranial::CN II Vision
|
2.3%
1/43 • Number of events 1
|
|
Nervous system disorders
Neuropathy: cranial::CN V Motor-jaw muscles; Sensory-facial
|
4.7%
2/43 • Number of events 2
|
|
Nervous system disorders
Neuropathy: cranial::CN VII Motor-face; Sensory-taste
|
2.3%
1/43 • Number of events 1
|
|
Nervous system disorders
Neuropathy: cranial::CN VIII Hearing and balance
|
2.3%
1/43 • Number of events 2
|
|
Nervous system disorders
Neuropathy: motor
|
25.6%
11/43 • Number of events 12
|
|
Nervous system disorders
Neuropathy: sensory
|
14.0%
6/43 • Number of events 10
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
18.6%
8/43 • Number of events 16
|
Additional Information
Kevin Camphausen, M.D.
National Cancer Institute, national Institutes of Health
Phone: 301-496-5457
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place