Trial Outcomes & Findings for Temozolomide and Radiation Therapy in Treating Patients With Gliomas (NCT NCT00114140)

Last Updated: 2024-07-08

Results Overview

Survival time is defined as time from registration to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. This analysis was planned to occur when all patients had been potentially followed for at least 3 years.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

136 participants

Primary outcome timeframe

Registration to 3 years

Results posted on

2024-07-08

Participant Flow

Participant milestones

Participant milestones
Measure	Temozolomide + Radiation Therapy (RT) Daily temozolomide plus concurrent radiotherapy followed by temozolomide
Overall Study STARTED	136
Overall Study COMPLETED	129
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Temozolomide + Radiation Therapy (RT) Daily temozolomide plus concurrent radiotherapy followed by temozolomide
Overall Study Protocol Violation	7

Baseline Characteristics

Temozolomide and Radiation Therapy in Treating Patients With Gliomas

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Temozolomide + Radiation Therapy (RT) n=129 Participants Daily temozolomide plus concurrent radiotherapy followed by temozolomide
Age, Continuous	49 years n=5 Participants
Sex: Female, Male Female	54 Participants n=5 Participants
Sex: Female, Male Male	75 Participants n=5 Participants

PRIMARY outcome

Timeframe: Registration to 3 years

Population: Eligible patients

Outcome measures

Outcome measures
Measure	Temozolomide + Radiation Therapy (RT) n=129 Participants Daily temozolomide plus concurrent radiotherapy followed by temozolomide	Temozolomide + Radiation Therapy (RT) - Unmethylated Daily temozolomide plus concurrent radiotherapy followed by temozolomide - Patients with unmethylated status	Temozolomide + Radiation Therapy (RT) at 12 Months Daily temozolomide plus concurrent radiotherapy followed by temozolomide
Overall Survival Rate at 3 Years	73.1 percentage of participants Interval 65.3 to 80.8	—	—

PRIMARY outcome

Timeframe: From registration to last follow-up, up to 7.1 years. Analysis occurs after all patients have been on study for at least 3 years.

Population: Eligible patients

Progressive Disease (PD) is defined as 25% or \> increase in the cross-sectional area of enhancing or non-enhancing tumor on consecutive MRI scans, or any new area(s) of tumor. Under exceptional circumstances, disease progression may be declared in the absence of an increase in tumor size based on "clinical deterioration" including the need for increasing doses of steroid and/or a worsening Karnofsky Performance Status(KPS) / Neurologic Function Score(NFS). Progression-free survival time is defined as time from registration to date of progressive disease or death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Median survival time is reported.

Outcome measures

Outcome measures
Measure	Temozolomide + Radiation Therapy (RT) n=129 Participants Daily temozolomide plus concurrent radiotherapy followed by temozolomide	Temozolomide + Radiation Therapy (RT) - Unmethylated Daily temozolomide plus concurrent radiotherapy followed by temozolomide - Patients with unmethylated status	Temozolomide + Radiation Therapy (RT) at 12 Months Daily temozolomide plus concurrent radiotherapy followed by temozolomide
Progression-free Survival	4.5 years Interval 3.5 to Upper limit not reached	—	—

PRIMARY outcome

Timeframe: Registration to 3 years

Population: Eligible patients with O(6)-methylguanine-DNA methyltransferase (MGMT) status

Survival time is defined as time from registration to date of death from any cause. Progressive Disease (PD) is defined as 25% or \> increase in the cross-sectional area of enhancing or non-enhancing tumor on consecutive MRI scans, or any new area(s) of tumor. Under exceptional circumstances, disease progression may be declared in the absence of an increase in tumor size based on "clinical deterioration" including the need for increasing doses of steroid and/or a worsening Karnofsky Performance Status(KPS) / Neurologic Function Score(NFS). Survival and progression-free survival are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.

Outcome measures

Outcome measures
Measure	Temozolomide + Radiation Therapy (RT) n=57 Participants Daily temozolomide plus concurrent radiotherapy followed by temozolomide	Temozolomide + Radiation Therapy (RT) - Unmethylated n=18 Participants Daily temozolomide plus concurrent radiotherapy followed by temozolomide - Patients with unmethylated status	Temozolomide + Radiation Therapy (RT) at 12 Months Daily temozolomide plus concurrent radiotherapy followed by temozolomide
Survival and Progression-free Survival by O(6)-Methylguanine-DNA Methyltransferase (MGMT) Methylation Status Overall Survival	NA years Interval 5.9 to Upper limit was not reached	3.0 years Interval 2.3 to Upper limit was not reached	—
Survival and Progression-free Survival by O(6)-Methylguanine-DNA Methyltransferase (MGMT) Methylation Status Progression-free Survival	NA years Interval 4.5 to Median and upper limit were not reached	2.0 years Interval 0.9 to 4.9	—

PRIMARY outcome

Timeframe: Baseline, 6 months, and 12 months.

Population: Eligible patients entered after QOL component amendment and alive at 6 and 12 months for respective post-baseline endpoints.

Functional Assessment of Cancer Therapy Scale with brain module (FACT-BR): a 50-question self-report questionnaire contains the following domains (scales): Physical well-being (7 questions totalling 0-28), social/family well-being (7 questions totalling 0-28), emotional well-being (6 questions totalling 0-24), functional well-being (7 questions totalling 0-28) and brain cancer subscale which contains concerns relevant to patients with brain tumors (19 questions totalling 0-76). Each question has a value 0-4. For some questions a higher indicates better outcome and others are the opposite. The former are summed as is, the latter are reversed in value before adding, such that each domain ranges from 0 to 4 multiplied by the number of questions in the domain, with 0 indicating worst and the highest possible value indicating best outcome. The FACT-Br total (0-184) is obtained by adding all domains together if the overall question response rate is greater than 80%.

Outcome measures

Outcome measures
Measure	Temozolomide + Radiation Therapy (RT) n=97 Participants Daily temozolomide plus concurrent radiotherapy followed by temozolomide	Temozolomide + Radiation Therapy (RT) - Unmethylated n=95 Participants Daily temozolomide plus concurrent radiotherapy followed by temozolomide - Patients with unmethylated status	Temozolomide + Radiation Therapy (RT) at 12 Months n=92 Participants Daily temozolomide plus concurrent radiotherapy followed by temozolomide
Quality of Life as Measured by the Functional Assessment of Cancer Therapy Scale With Brain Module (FACT-BR) Physical Well-Being	23 units on a scale Interval 5.0 to 28.0	22 units on a scale Interval 3.0 to 28.0	23 units on a scale Interval 8.0 to 28.0
Quality of Life as Measured by the Functional Assessment of Cancer Therapy Scale With Brain Module (FACT-BR) Social/Family Well-Being	24.5 units on a scale Interval 7.0 to 28.0	24.0 units on a scale Interval 9.0 to 28.0	24.3 units on a scale Interval 8.0 to 28.0
Quality of Life as Measured by the Functional Assessment of Cancer Therapy Scale With Brain Module (FACT-BR) Emotional Well-Being	18.5 units on a scale Interval 4.0 to 24.0	20.0 units on a scale Interval 11.0 to 24.0	23.0 units on a scale Interval 6.0 to 24.0
Quality of Life as Measured by the Functional Assessment of Cancer Therapy Scale With Brain Module (FACT-BR) Functional Well-Being	17.0 units on a scale Interval 2.0 to 28.0	18.0 units on a scale Interval 4.0 to 28.0	19.5 units on a scale Interval 2.0 to 28.0
Quality of Life as Measured by the Functional Assessment of Cancer Therapy Scale With Brain Module (FACT-BR) Brain Cancer Subscale	54.0 units on a scale Interval 23.0 to 76.0	52.0 units on a scale Interval 22.0 to 75.0	59.0 units on a scale Interval 19.0 to 76.0
Quality of Life as Measured by the Functional Assessment of Cancer Therapy Scale With Brain Module (FACT-BR) FACT-Br Total	135.3 units on a scale Interval 69.5 to 184.0	129.9 units on a scale Interval 87.0 to 176.0	140.0 units on a scale Interval 65.0 to 181.0

PRIMARY outcome

Timeframe: Baseline, 6 months, and 12 months.

Population: Eligible patients entered after QOL component amendment with baseline score and alive at 6 and 12 months for respective timepoint.

Hopkins Verbal Learning Test (HVLT) is a test measuring learning memory retrieval, and memory consolidation processes.; Controlled Oral Word Association Test (COWAT) is a test of phonemic verbal fluency. The patient produces as many words as possible in 1 min. (each) for a specific letter (C, F, L or P, R, W).; Trail Making Test (TMT) is a measure of visuospatial scanning, attention, sequencing, and speed in Part A (TMT A) and executive function in Part B (TMT B). Patients must "connect the dots" either in a numbered sequence or alternating letters and numbers. Difference between pre-treatment baseline and follow-up assessment scores determined by the reliable change (RC) index, using a 90% confidence interval to designate statistically significant change.

Outcome measures

Outcome measures
Measure	Temozolomide + Radiation Therapy (RT) n=95 Participants Daily temozolomide plus concurrent radiotherapy followed by temozolomide	Temozolomide + Radiation Therapy (RT) - Unmethylated n=92 Participants Daily temozolomide plus concurrent radiotherapy followed by temozolomide - Patients with unmethylated status	Temozolomide + Radiation Therapy (RT) at 12 Months Daily temozolomide plus concurrent radiotherapy followed by temozolomide
Neurocognitive Function HVLT Recall Status: Deterioration	11 participants	8 participants	—
Neurocognitive Function HVLT Recall Status: No change	26 participants	22 participants	—
Neurocognitive Function HVLT Recall Status: Improvement	13 participants	15 participants	—
Neurocognitive Function COWA Status: Deterioration	1 participants	3 participants	—
Neurocognitive Function COWA Status: No change	42 participants	28 participants	—
Neurocognitive Function COWA Status: Improvement	6 participants	12 participants	—
Neurocognitive Function TMT A Status: Deterioration	15 participants	7 participants	—
Neurocognitive Function TMT A Status: No change	24 participants	24 participants	—
Neurocognitive Function TMT A Status: Improvement	11 participants	14 participants	—
Neurocognitive Function TMT B Status: Deterioration	11 participants	7 participants	—
Neurocognitive Function TMT B Status: No change	27 participants	22 participants	—
Neurocognitive Function TMT B Status: Improvement	11 participants	15 participants	—

Adverse Events

Temozolomide + Radiation Therapy (RT)

Serious events: 37 serious events

Other events: 129 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Temozolomide + Radiation Therapy (RT) n=129 participants at risk Daily temozolomide plus concurrent radiotherapy followed by temozolomide
Nervous system disorders Cognitive disorder	0.78% 1/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Convulsions NOS	10.1% 13/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Depressed level of consciousness	0.78% 1/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Dizziness	0.78% 1/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Encephalopathy	1.6% 2/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Headache	0.78% 1/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Hemorrhagic stroke	0.78% 1/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Memory impairment	0.78% 1/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Peripheral motor neuropathy	1.6% 2/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Peripheral sensory neuropathy	0.78% 1/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Tremor	0.78% 1/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Psychiatric disorders Confusional state	1.6% 2/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Psychiatric disorders Personality change	0.78% 1/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Reproductive system and breast disorders Uterine hemorrhage	0.78% 1/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Aspiration	0.78% 1/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.78% 1/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.78% 1/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Alopecia	0.78% 1/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Dermatitis exfoliative NOS	0.78% 1/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Erythema multiforme	0.78% 1/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Vascular disorders Hypertension NOS	0.78% 1/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Vascular disorders Thrombosis	2.3% 3/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Blood and lymphatic system disorders Blood/bone marrow - Other:	0.78% 1/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Cardiac disorders Atrial tachycardia	0.78% 1/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Ear and labyrinth disorders Hearing impaired	0.78% 1/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Eye disorders Dry eye NOS	0.78% 1/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Abdominal pain NOS	1.6% 2/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Constipation	0.78% 1/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Nausea	0.78% 1/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Small intestinal stricture NOS	0.78% 1/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Vomiting NOS	0.78% 1/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Disease progression NOS	0.78% 1/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Fatigue	4.7% 6/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Pain - Other:	0.78% 1/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Immune system disorders Hypersensitivity NOS	0.78% 1/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Infection - Other:	1.6% 2/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Infectous meningitis	0.78% 1/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Pneumonia NOS	0.78% 1/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Urinary tract infection NOS	0.78% 1/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Injury, poisoning and procedural complications Fracture NOS	0.78% 1/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Alanine aminotransferase increased	0.78% 1/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Leukopenia NOS	1.6% 2/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Lymphopenia	0.78% 1/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Neutrophil count	2.3% 3/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Platelet count decreased	6.2% 8/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Dehydration	1.6% 2/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hyperglycaemia NOS	0.78% 1/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hyponatremia	1.6% 2/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Musculoskeletal and connective tissue disorders Muscle weakness, generalized or specific area (not due to neuropathy): Extremity-lower	0.78% 1/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Musculoskeletal and connective tissue disorders Neck pain	0.78% 1/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Secondary Malignancy - possibly related to cancer treatment	0.78% 1/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Cerebral ischaemia	0.78% 1/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.

Other adverse events

Other adverse events
Measure	Temozolomide + Radiation Therapy (RT) n=129 participants at risk Daily temozolomide plus concurrent radiotherapy followed by temozolomide
Blood and lymphatic system disorders Hemoglobin	41.1% 53/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Ear and labyrinth disorders Hearing impaired	8.5% 11/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Eye disorders Ocular/visual - Other:	6.2% 8/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Eye disorders Vision blurred	7.8% 10/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Abdominal pain NOS	5.4% 7/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Constipation	47.3% 61/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Diarrhoea NOS	20.9% 27/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Dry mouth	8.5% 11/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Dyspepsia	7.8% 10/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Gastrointestinal - Other:	7.8% 10/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Nausea	74.4% 96/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Vomiting NOS	42.6% 55/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Edema: limb:	5.4% 7/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Fatigue	89.1% 115/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Pain - Other:	7.0% 9/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Pyrexia	6.2% 8/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Injury, poisoning and procedural complications Dermatitis radiation NOS	27.9% 36/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Injury, poisoning and procedural complications Radiation recall syndrome	7.8% 10/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Alanine aminotransferase increased	29.5% 38/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Aspartate aminotransferase increased	20.9% 27/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Blood alkaline phosphatase increased	13.2% 17/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Blood creatinine increased	9.3% 12/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Gamma-glutamyltransferase increased	9.3% 12/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Leukopenia NOS	51.9% 67/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Lymphopenia	44.2% 57/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Metabolic/laboratory - Other:	10.9% 14/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Neutrophil count	27.1% 35/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Platelet count decreased	45.0% 58/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Weight decreased	21.7% 28/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Anorexia	44.2% 57/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Dehydration	7.0% 9/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hypercalcaemia	5.4% 7/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hyperglycaemia NOS	38.0% 49/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hypernatremia	7.8% 10/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hypoalbuminemia	10.1% 13/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hypocalcemia	8.5% 11/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hypoglycemia NOS	7.0% 9/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hypokalemia	12.4% 16/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hyponatremia	11.6% 15/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Musculoskeletal and connective tissue disorders Arthralgia	6.2% 8/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Musculoskeletal and connective tissue disorders Muscle weakness, generalized or specific area (not due to neuropathy): Extremity-lower	8.5% 11/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Musculoskeletal and connective tissue disorders Myalgia	6.2% 8/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Ataxia	7.8% 10/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Cognitive disorder	12.4% 16/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Convulsions NOS	34.9% 45/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Dizziness	24.0% 31/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Dysgeusia	24.8% 32/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Headache	58.9% 76/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Memory impairment	38.0% 49/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Neurology - Other:	10.1% 13/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Peripheral motor neuropathy	9.3% 12/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Peripheral sensory neuropathy	19.4% 25/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Speech disorder	10.9% 14/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Tremor	10.9% 14/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Psychiatric disorders Anxiety	12.4% 16/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Psychiatric disorders Confusional state	10.1% 13/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Psychiatric disorders Depression	15.5% 20/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Psychiatric disorders Insomnia	26.4% 34/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Psychiatric disorders Personality change	5.4% 7/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Renal and urinary disorders Pollakiuria	6.2% 8/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Cough	14.7% 19/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Dyspnoea	9.3% 12/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Alopecia	68.2% 88/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Dermatitis exfoliative NOS	14.7% 19/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Dermatology/skin - Other:	6.2% 8/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Pruritus	7.8% 10/129 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.

Additional Information

Wendy Seiferheld, M.S.

NRG Oncology

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place