Trial Outcomes & Findings for A Phase II Study of Optune (NovoTTF) in Combination With Bevacizumab (BEV) and Temozolomide (TMZ) in Patients With Newly Diagnosed Unresectable Glioblastoma (GBM) (NCT NCT02343549)

Last Updated: 2022-11-03

Results Overview

Twelve-month survival was determined for each subject as a binary variable indicating whether or not the subject was alive at 12 months from initiation of chemoradiation. Determination of this endpoint occurs after the subject has at least 12 months of follow-up, unless they have died sooner.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

13 participants

Primary outcome timeframe

Evaluated over 12 months

Results posted on

2022-11-03

Participant Flow

Participant milestones

Participant milestones
Measure	Planned RT + TMZ + BEV + NovoTTF100A Device Best standard of care radiation therapy (RT, 2 Gy given daily 5 days per week), temozolomide (TMZ, 75 mg/m2 administered daily), and bevacizumab (BEV, 10 mg/kg administered every 2 weeks as an IV infusion) for 6 weeks. After completion of chemoradiation, NovoTTF100A system was initiated, to be worn on average 18 hours or more a day for up to 12 months. The patients also continued with maintenance TMZ/BEV.
Overall Study STARTED	13
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Planned RT + TMZ + BEV + NovoTTF100A Device Best standard of care radiation therapy (RT, 2 Gy given daily 5 days per week), temozolomide (TMZ, 75 mg/m2 administered daily), and bevacizumab (BEV, 10 mg/kg administered every 2 weeks as an IV infusion) for 6 weeks. After completion of chemoradiation, NovoTTF100A system was initiated, to be worn on average 18 hours or more a day for up to 12 months. The patients also continued with maintenance TMZ/BEV.
Overall Study Death	11
Overall Study Withdrawal by Subject	2

Baseline Characteristics

A Phase II Study of Optune (NovoTTF) in Combination With Bevacizumab (BEV) and Temozolomide (TMZ) in Patients With Newly Diagnosed Unresectable Glioblastoma (GBM)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Planned RT + TMZ + BEV + NovoTTF100A Device n=13 Participants Best standard of care radiation therapy (RT, 2 Gy given daily 5 days per week), temozolomide (TMZ, 75 mg/m2 administered daily), and bevacizumab (BEV, 10 mg/kg administered every 2 weeks as an IV infusion) for 6 weeks. After completion of chemoradiation, NovoTTF100A system was initiated, to be worn on average 18 hours or more a day for up to 12 months. The patients also continued with maintenance TMZ/BEV.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Age, Continuous	62 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 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	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants
Karnofsky Performance Scale 100 - Normal, no complains, no evidence of disease	1 Participants n=5 Participants
Karnofsky Performance Scale 90 - Able to carry on normal activity; minor signs or symptoms of disease	4 Participants n=5 Participants
Karnofsky Performance Scale 80 - Normal activity with effort; some signs or symptoms of disease	3 Participants n=5 Participants
Karnofsky Performance Scale 70 - Cares for self, unable to carry on normal activity or to do active work	4 Participants n=5 Participants
Karnofsky Performance Scale 60 - Requires occasional assistance, but is able to care for most of his/her needs	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Evaluated over 12 months

Population: The evaluable population for efficacy includes subjects who receive initial placement of the NovoTTF100A transducer arrays. Note: 4 subjects discontinued study participation prior to device placement but after initiation of RT+TMZ+BEV, and are therefore are excluded from efficacy analyses.

Outcome measures

Outcome measures
Measure	Planned RT + TMZ + BEV + NovoTTF100A Device n=9 Participants Best standard of care radiation therapy (RT, 2 Gy given daily 5 days per week), temozolomide (TMZ, 75 mg/m2 administered daily), and bevacizumab (BEV, 10 mg/kg administered every 2 weeks as an IV infusion) for 6 weeks. After completion of chemoradiation, NovoTTF100A system was initiated, to be worn on average 18 hours or more a day for up to 12 months. The patients also continued with maintenance TMZ/BEV.
Number of Participants With 12-Month Survival	3 Participants

SECONDARY outcome

Timeframe: From date of treatment start to date of death, or censored as described above; assessed for approximately 5 years

Overall survival was defined as the duration from the initiation of chemoradiation therapy to the date of death from any cause. Subjects who were alive or lost to follow-up at the time of the analysis were be censored at the last known date they were alive.

Outcome measures

Outcome measures
Measure	Planned RT + TMZ + BEV + NovoTTF100A Device n=9 Participants Best standard of care radiation therapy (RT, 2 Gy given daily 5 days per week), temozolomide (TMZ, 75 mg/m2 administered daily), and bevacizumab (BEV, 10 mg/kg administered every 2 weeks as an IV infusion) for 6 weeks. After completion of chemoradiation, NovoTTF100A system was initiated, to be worn on average 18 hours or more a day for up to 12 months. The patients also continued with maintenance TMZ/BEV.
Overall Survival (OS)	9.9 months Interval 4.8 to 12.8

SECONDARY outcome

Timeframe: From date of treatment start to date of progression/death, or censored as described above; assessed for approximately 2 years.

Progression-Free Survival (PFS) is defined as duration of time from initiation of chemoradiation therapy to first occurrence of either progressive disease (PD) or death. PD must be objectively determined as per RANO criteria (Updated Response Assessment Criteria for High Grade Gliomas, where PD is defined as a 25% increase in sum of products of diameters from nadir), where date of PD is date of assessment that identified PD. If subject died without documented PD, date of progression will be date of death. For surviving subjects who do not have documented PD, PFS will be censored at date of last radiologic assessment. For subjects who receive subsequent anti-cancer therapy prior to documented PD, PFS will be censored at the date of last radiologic assessment prior to the commencement of subsequent therapy. Subjects who have an initial PFS event immediately following 2 or more consecutive missed assessments will be censored at date of last assessment prior to missed assessments.

Outcome measures

Outcome measures
Measure	Planned RT + TMZ + BEV + NovoTTF100A Device n=9 Participants Best standard of care radiation therapy (RT, 2 Gy given daily 5 days per week), temozolomide (TMZ, 75 mg/m2 administered daily), and bevacizumab (BEV, 10 mg/kg administered every 2 weeks as an IV infusion) for 6 weeks. After completion of chemoradiation, NovoTTF100A system was initiated, to be worn on average 18 hours or more a day for up to 12 months. The patients also continued with maintenance TMZ/BEV.
Progression Free Survival (PFS)	7.9 months Interval 4.8 to 10.4

SECONDARY outcome

Timeframe: From enrollment to best response while on study treatment; subjects remained on treatment until disease progression or death or unacceptable toxicity (subjects were on treatment for an average of 7 months)

Objective response was determined for each subject as a binary variable indicating whether or not the subject achieved a best overall response of complete response (CR) or partial response (PR) as determined by the Updated Response Assessment Criteria for High Grade Gliomas (RANO; where CR is indicated by disappearance of all target lesions and PR is indicated by \>=50% decrease in the sum of products of diameters of target lesions with baseline as reference). Best responses of CR or PR must be confirmed by a subsequent radiologic assessment.

Outcome measures

Outcome measures
Measure	Planned RT + TMZ + BEV + NovoTTF100A Device n=9 Participants Best standard of care radiation therapy (RT, 2 Gy given daily 5 days per week), temozolomide (TMZ, 75 mg/m2 administered daily), and bevacizumab (BEV, 10 mg/kg administered every 2 weeks as an IV infusion) for 6 weeks. After completion of chemoradiation, NovoTTF100A system was initiated, to be worn on average 18 hours or more a day for up to 12 months. The patients also continued with maintenance TMZ/BEV.
Number of Participants With Objective Response	3 Participants

SECONDARY outcome

Disease control was determined for each subject indicating whether or not they achieved an overall response of stable disease (SD) or better by RANO criteria (where a CR is indicated by disappearance of all target and non target lesions, a PR is indicated by \>= 50% decrease in sum of products of diameters of target lesions with baseline as reference, and SD is neither sufficient shrinkage to qualify for PR nor sufficient growth, \>=25%, to indicate progression).

Outcome measures

Outcome measures
Measure	Planned RT + TMZ + BEV + NovoTTF100A Device n=9 Participants Best standard of care radiation therapy (RT, 2 Gy given daily 5 days per week), temozolomide (TMZ, 75 mg/m2 administered daily), and bevacizumab (BEV, 10 mg/kg administered every 2 weeks as an IV infusion) for 6 weeks. After completion of chemoradiation, NovoTTF100A system was initiated, to be worn on average 18 hours or more a day for up to 12 months. The patients also continued with maintenance TMZ/BEV.
Number of Participants With Disease Control	9 Participants

SECONDARY outcome

Timeframe: From date of first response to date of progression/death, or censored as described above; assessed for approximately 2 years.

Population: The evaluable population for efficacy includes subjects who receive initial placement of the NovoTTF100A transducer arrays. Note: 4 subjects discontinued study participation prior to device placement, and are therefore are excluded from efficacy analyses. Duration of response was conducted specifically on those subjects in the efficacy population who achieved objective response (PR or CR).

Duration of response (DOR) was measured from the time RANO criteria are met for CR or PR (whichever is first recorded) until the first occurrence of either progressive disease or death. PD must be objectively determined as per RANO criteria (Updated Response Assessment Criteria for High Grade Gliomas, where PD is defined as a 25% increase in sum of products of diameters from nadir), where PD date is assessment date that identified PD. If subject died without PD, PD date was death date. For surviving subjects who didn't have documented PD, DOR was censored at last radiologic assessment. For subjects who receive subsequent anti-cancer therapy prior to documented PD, DOR was censored at last radiologic assessment prior to commencement of subsequent therapy. Subjects who had an initial PD event immediately following 2 or more consecutive missed assessments were censored at last assessment prior to missed assessments. DOR was only calculated for subjects with a best response of PR or CR.

Outcome measures

Outcome measures
Measure	Planned RT + TMZ + BEV + NovoTTF100A Device n=3 Participants Best standard of care radiation therapy (RT, 2 Gy given daily 5 days per week), temozolomide (TMZ, 75 mg/m2 administered daily), and bevacizumab (BEV, 10 mg/kg administered every 2 weeks as an IV infusion) for 6 weeks. After completion of chemoradiation, NovoTTF100A system was initiated, to be worn on average 18 hours or more a day for up to 12 months. The patients also continued with maintenance TMZ/BEV.
Duration of Response	8.1 months Interval 3.7 to 8.6

SECONDARY outcome

Timeframe: From date of treatment start to date of progression/death, or censored as described above; assessed for approximately 2 years.

Duration of disease control (DoDC) was measured from the time of initiation of chemoradiation therapy until the first occurrence of either progressive disease or death. PD must be objectively determined as per RANO criteria (Updated Response Assessment Criteria for High Grade Gliomas, where PD is defined as a 25% increase in sum of products of diameters from nadir), where PD date is assessment date that identified PD. If subject died without PD, PD date was death date. For surviving subjects who didn't have documented PD, DoDC was censored at last radiologic assessment. For subjects who receive subsequent anti-cancer therapy prior to documented PD, DoDC was censored at last radiologic assessment prior to commencement of subsequent therapy. Subjects who had an initial PD event immediately following 2 or more consecutive missed assessments were censored at last assessment prior to missed assessments. DoDC was calculated only for subjects with a best overall response of SD or better.

Outcome measures

Outcome measures
Measure	Planned RT + TMZ + BEV + NovoTTF100A Device n=9 Participants Best standard of care radiation therapy (RT, 2 Gy given daily 5 days per week), temozolomide (TMZ, 75 mg/m2 administered daily), and bevacizumab (BEV, 10 mg/kg administered every 2 weeks as an IV infusion) for 6 weeks. After completion of chemoradiation, NovoTTF100A system was initiated, to be worn on average 18 hours or more a day for up to 12 months. The patients also continued with maintenance TMZ/BEV.
Duration of Disease Control	7.9 months Interval 4.8 to 10.4

Adverse Events

Planned RT + TMZ + BEV + NovoTTF100A Device

Serious events: 8 serious events

Other events: 13 other events

Deaths: 11 deaths

Serious adverse events

Serious adverse events
Measure	Planned RT + TMZ + BEV + NovoTTF100A Device n=13 participants at risk Best standard of care radiation therapy (RT, 2 Gy given daily 5 days per week), temozolomide (TMZ, 75 mg/m2 administered daily), and bevacizumab (BEV, 10 mg/kg administered every 2 weeks as an IV infusion) for 6 weeks. After completion of chemoradiation, NovoTTF100A system was initiated, to be worn on average 18 hours or more a day for up to 12 months. The patients also continued with maintenance TMZ/BEV.
Nervous system disorders Encephalopathy	23.1% 3/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Nervous system disorders Seizure	15.4% 2/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Respiratory, thoracic and mediastinal disorders Adult respiratory distress syndrome	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Metabolism and nutrition disorders Dehydration	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Nervous system disorders Facial muscle weakness	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Nervous system disorders Headache	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Metabolism and nutrition disorders Hyperglycemia	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Metabolism and nutrition disorders Hyponatremia	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Nervous system disorders Intracranial hemorrhage	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Musculoskeletal and connective tissue disorders Muscle weakness right-sided	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Musculoskeletal and connective tissue disorders Pain in extremity	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Respiratory, thoracic and mediastinal disorders Pneumonitis	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Respiratory, thoracic and mediastinal disorders Productive cough	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Infections and infestations Urinary tract infection	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.

Other adverse events

Other adverse events
Measure	Planned RT + TMZ + BEV + NovoTTF100A Device n=13 participants at risk Best standard of care radiation therapy (RT, 2 Gy given daily 5 days per week), temozolomide (TMZ, 75 mg/m2 administered daily), and bevacizumab (BEV, 10 mg/kg administered every 2 weeks as an IV infusion) for 6 weeks. After completion of chemoradiation, NovoTTF100A system was initiated, to be worn on average 18 hours or more a day for up to 12 months. The patients also continued with maintenance TMZ/BEV.
Investigations Platelet count decreased	46.2% 6/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
General disorders Fatigue	84.6% 11/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Skin and subcutaneous tissue disorders Alopecia	76.9% 10/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Injury, poisoning and procedural complications Fall	69.2% 9/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Metabolism and nutrition disorders Anorexia	61.5% 8/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Nervous system disorders Headache	53.8% 7/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	53.8% 7/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Gastrointestinal disorders Nausea	46.2% 6/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Psychiatric disorders Confusion	38.5% 5/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Gastrointestinal disorders Constipation	38.5% 5/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Nervous system disorders Dysgeusia	38.5% 5/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Skin and subcutaneous tissue disorders Skin ulceration	38.5% 5/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Psychiatric disorders Depression	30.8% 4/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
General disorders Gait disturbance	30.8% 4/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Nervous system disorders Memory impairment	30.8% 4/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Investigations Weight loss	30.8% 4/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Injury, poisoning and procedural complications Dermatitis radiation	30.8% 4/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Psychiatric disorders Anxiety	23.1% 3/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Eye disorders Blurred vision	23.1% 3/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Metabolism and nutrition disorders Dehydration	23.1% 3/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Gastrointestinal disorders Dysphagia	23.1% 3/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Nervous system disorders Dysphasia	23.1% 3/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Respiratory, thoracic and mediastinal disorders Epistaxis	23.1% 3/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Skin and subcutaneous tissue disorders Erythema multiforme	23.1% 3/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Metabolism and nutrition disorders Hypokalemia	23.1% 3/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Metabolism and nutrition disorders Hypomagnesemia	23.1% 3/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Psychiatric disorders Insomnia	23.1% 3/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Vascular disorders Thromboembolic event	23.1% 3/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Renal and urinary disorders Urinary incontinence	23.1% 3/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Infections and infestations Urinary tract infection	23.1% 3/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
General disorders Localized edema	23.1% 3/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Musculoskeletal and connective tissue disorders Muscle weakness left-sided	23.1% 3/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Gastrointestinal disorders Bloating	15.4% 2/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Injury, poisoning and procedural complications Bruising	15.4% 2/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Nervous system disorders Cognitive disturbance	15.4% 2/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Gastrointestinal disorders Diarrhea	15.4% 2/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Nervous system disorders Dizziness	15.4% 2/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Gastrointestinal disorders Dry mouth	15.4% 2/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Respiratory, thoracic and mediastinal disorders Dyspnea	15.4% 2/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Nervous system disorders Encephalopathy	15.4% 2/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Respiratory, thoracic and mediastinal disorders Hoarseness	15.4% 2/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Vascular disorders Hypertension	15.4% 2/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Metabolism and nutrition disorders Hyponatremia	15.4% 2/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Respiratory, thoracic and mediastinal disorders Nasal congestion	15.4% 2/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Musculoskeletal and connective tissue disorders Pain in extremity	15.4% 2/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Psychiatric disorders Personality change	15.4% 2/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Skin and subcutaneous tissue disorders Photosensitivity	15.4% 2/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Skin and subcutaneous tissue disorders Rash acneiform	15.4% 2/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Nervous system disorders Seizure	15.4% 2/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Gastrointestinal disorders Vomiting	15.4% 2/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Investigations Weight gain	15.4% 2/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Nervous system disorders Facial muscle weakness	15.4% 2/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Infections and infestations Mucosal infection	15.4% 2/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	15.4% 2/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Musculoskeletal and connective tissue disorders Muscle weakness right-sided	15.4% 2/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Renal and urinary disorders Acute kidney injury	15.4% 2/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Endocrine disorders Adrenal insufficiency	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Investigations Alanine aminotransferase increased	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Nervous system disorders Amnesia	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Musculoskeletal and connective tissue disorders Arthralgia	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Cardiac disorders Atrial fibrillation	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Musculoskeletal and connective tissue disorders Back pain	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Skin and subcutaneous tissue disorders Bullous dermatitis	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Cardiac disorders Cardiac disorders - Other	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Investigations CD4 lymphocytes decreased	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
General disorders Chills	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Eye disorders Conjunctivitis	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Respiratory, thoracic and mediastinal disorders Cough	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Nervous system disorders Depressed level of consciousness	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Nervous system disorders Dysarthria	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Gastrointestinal disorders Dyspepsia	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Ear and labyrinth disorders Ear pain	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
General disorders Edema face	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Eye disorders Eye disorders - Other	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
General disorders Fever	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Gastrointestinal disorders Flatulence	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Renal and urinary disorders Hematuria	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Skin and subcutaneous tissue disorders Hyperhidrosis	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Metabolism and nutrition disorders Hypocalcemia	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Respiratory, thoracic and mediastinal disorders Hypoxia	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Gastrointestinal disorders Ileus	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Infections and infestations Infections and infestations - Other	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Nervous system disorders Lethargy	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Investigations Lymphocyte count decreased	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
General disorders Malaise	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Gastrointestinal disorders Oral hemorrhage	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
General disorders Pain	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Nervous system disorders Paresthesia	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Cardiac disorders Pericardial effusion	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Respiratory, thoracic and mediastinal disorders Postnasal drip	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Respiratory, thoracic and mediastinal disorders Productive cough	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Skin and subcutaneous tissue disorders Pruritus	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Psychiatric disorders Psychosis	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Skin and subcutaneous tissue disorders Rash maculo-papular	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Gastrointestinal disorders Rectal hemorrhage	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Renal and urinary disorders Renal and urinary disorders - Other	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Psychiatric disorders Restlessness	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Cardiac disorders Sinus tachycardia	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Infections and infestations Skin infection	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Nervous system disorders Somnolence	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Respiratory, thoracic and mediastinal disorders Sore throat	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Ear and labyrinth disorders Tinnitus	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Nervous system disorders Tremor	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Infections and infestations Upper respiratory infection	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Renal and urinary disorders Urinary frequency	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Renal and urinary disorders Urinary urgency	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Reproductive system and breast disorders Vaginal discharge	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Infections and infestations Vaginal infection	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Reproductive system and breast disorders Vaginal inflammation	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Ear and labyrinth disorders Vertigo	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Eye disorders Watering eyes	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Respiratory, thoracic and mediastinal disorders Wheezing	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Skin and subcutaneous tissue disorders Scalp pain	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
General disorders Edema limbs	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Metabolism and nutrition disorders Glucose intolerance	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Gastrointestinal disorders Hemorrhoidal hemorrhage	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Infections and infestations Lung infection	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Renal and urinary disorders Urinary tract pain	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
General disorders Non-cardiac chest pain	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other	7.7% 1/13 • Baseline, during treatment [concurrent chemoradiation phase (6 weeks +/- 7 days, pre-NovoTTF100A system treatment (up to 2 weeks), NovoTTF100A system treatment with TMZ/BEV maintenance for up to 12 cycles], and through 30 days after NovoTTF100A device is discontinued or 30 days after last dose of study treatment for those who do not have NovoTTF100A device placed, up to approximately 66 weeks.

Additional Information

Chair of Biostatistics Department

Levine Cancer Institute

Phone: 9804422371

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place