Trial Outcomes & Findings for TTFields and Pulsed Bevacizumab for Recurrent Glioblastoma (NCT NCT02663271)
NCT ID: NCT02663271
Last Updated: 2022-06-23
Results Overview
Overall survival is defined as time interval from date of starting Optune to date of death or censoring whichever happens first.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
from date of starting Optune to date of death or censoring, whichever comes first, assessed up to 24 months
Results posted on
2022-06-23
Participant Flow
Ten patients were assessed for eligibility in this study. One subject did not meet eligibility.
Participant milestones
| Measure |
Optune+Pulsed Bevacizumab
The subjects will undergo 12 months of planned continuous treatment with Optune. The treatment will begin at week 0 and will be continuous throughout the study. Pulsed bevacizumab dosing is defined by at least one cycle on and at least one cycle off. A cycle is defined as 8 weeks in length. If after one cycle on, there is no evidence of a repeat response; bevacizumab will be continued for one more cycle. If after two cycles on, there is no repeat response; bevacizumab will be continued with or without other standard chemotherapy until death. If after at least one cycle on, there is evidence of repeat response, bevacizumab will be discontinued for at least one cycle. In addition, the following will be performed: Bevacizumab will be given, physical examination and quality of life questionnaires will be performed and brain MRI.
Bevacizumab: Bevacizumab will be given at 10mg/kg IV every 2 weeks.
Optune: Optune will be worn continuously for 12 months. Optune is programmed by Novocure to deliver 200 kHz TTFields in two sequential, perpendicular field directions at a maximal intensity of 707mARMS. There will be no adjustments made to the device by investigators or patients/caregivers.
Brain MRI: Brain MRI will be done at screening and every 8 weeks.
Quality of Life Questionnaires: The quality of life questionnaires will be performed within 14 days of treatment and every 4 weeks.
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Optune+Pulsed Bevacizumab
The subjects will undergo 12 months of planned continuous treatment with Optune. The treatment will begin at week 0 and will be continuous throughout the study. Pulsed bevacizumab dosing is defined by at least one cycle on and at least one cycle off. A cycle is defined as 8 weeks in length. If after one cycle on, there is no evidence of a repeat response; bevacizumab will be continued for one more cycle. If after two cycles on, there is no repeat response; bevacizumab will be continued with or without other standard chemotherapy until death. If after at least one cycle on, there is evidence of repeat response, bevacizumab will be discontinued for at least one cycle. In addition, the following will be performed: Bevacizumab will be given, physical examination and quality of life questionnaires will be performed and brain MRI.
Bevacizumab: Bevacizumab will be given at 10mg/kg IV every 2 weeks.
Optune: Optune will be worn continuously for 12 months. Optune is programmed by Novocure to deliver 200 kHz TTFields in two sequential, perpendicular field directions at a maximal intensity of 707mARMS. There will be no adjustments made to the device by investigators or patients/caregivers.
Brain MRI: Brain MRI will be done at screening and every 8 weeks.
Quality of Life Questionnaires: The quality of life questionnaires will be performed within 14 days of treatment and every 4 weeks.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
|
Overall Study
Lack of Efficacy
|
1
|
Baseline Characteristics
TTFields and Pulsed Bevacizumab for Recurrent Glioblastoma
Baseline characteristics by cohort
| Measure |
Optune+Pulsed Bevacizumab
n=9 Participants
The subjects will undergo 12 months of planned continuous treatment with Optune. The treatment will begin at week 0 and will be continuous throughout the study. Pulsed bevacizumab dosing is defined by at least one cycle on and at least one cycle off. A cycle is defined as 8 weeks in length. If after one cycle on, there is no evidence of a repeat response; bevacizumab will be continued for one more cycle. If after two cycles on, there is no repeat response; bevacizumab will be continued with or without other standard chemotherapy until death. If after at least one cycle on, there is evidence of repeat response, bevacizumab will be discontinued for at least one cycle. In addition, the following will be performed: Bevacizumab will be given, physical examination and quality of life questionnaires will be performed and brain MRI.
Bevacizumab: Bevacizumab will be given at 10mg/kg IV every 2 weeks.
Optune: Optune will be worn continuously for 12 months. Optune is programmed by Novocure to deliver 200 kHz TTFields in two sequential, perpendicular field directions at a maximal intensity of 707mARMS. There will be no adjustments made to the device by investigators or patients/caregivers.
Brain MRI: Brain MRI will be done at screening and every 8 weeks.
Quality of Life Questionnaires: The quality of life questionnaires will be performed within 14 days of treatment and every 4 weeks.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=93 Participants
|
|
Age, Continuous
|
54.7 years
STANDARD_DEVIATION 11.5 • n=93 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: from date of starting Optune to date of death or censoring, whichever comes first, assessed up to 24 monthsPopulation: participants completing at least 8 weeks of treatment with the Optune device with compliance rate \> 60% in at least one 4-week period
Overall survival is defined as time interval from date of starting Optune to date of death or censoring whichever happens first.
Outcome measures
| Measure |
Optune+Pulsed Bevacizumab
n=3 Participants
The subjects will undergo 12 months of planned continuous treatment with Optune. The treatment will begin at week 0 and will be continuous throughout the study. Pulsed bevacizumab dosing is defined by at least one cycle on and at least one cycle off. A cycle is defined as 8 weeks in length. If after one cycle on, there is no evidence of a repeat response; bevacizumab will be continued for one more cycle. If after two cycles on, there is no repeat response; bevacizumab will be continued with or without other standard chemotherapy until death. If after at least one cycle on, there is evidence of repeat response, bevacizumab will be discontinued for at least one cycle. In addition, the following will be performed: Bevacizumab will be given, physical examination and quality of life questionnaires will be performed and brain MRI.
Bevacizumab: Bevacizumab will be given at 10mg/kg IV every 2 weeks.
Optune: Optune will be worn continuously for 12 months. Optune is programmed by Novocure to deliver 200 kHz TTFields in two sequential, perpendicular field directions at a maximal intensity of 707mARMS. There will be no adjustments made to the device by investigators or patients/caregivers.
Brain MRI: Brain MRI will be done at screening and every 8 weeks.
Quality of Life Questionnaires: The quality of life questionnaires will be performed within 14 days of treatment and every 4 weeks.
|
|---|---|
|
Overall Survival
|
7.4 months
Interval 5.0 to
insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Assessed up to 24 monthsPopulation: participants completing at least 8 weeks of treatment with the Optune device with compliance rate \> 60% in at least one 4-week period.
The Karnofsky Performance Scale is rated from 0 - 100 with 0 = death and 100 = normal without complaints or evidence of disease. A higher score means the patient is better able to carry out daily activities. Patients are evaluable for assessment of QoL after completing at least 8 weeks of treatment with the Optune device with compliance rate \> 60% in at least one 4-week period.
Outcome measures
| Measure |
Optune+Pulsed Bevacizumab
n=3 Participants
The subjects will undergo 12 months of planned continuous treatment with Optune. The treatment will begin at week 0 and will be continuous throughout the study. Pulsed bevacizumab dosing is defined by at least one cycle on and at least one cycle off. A cycle is defined as 8 weeks in length. If after one cycle on, there is no evidence of a repeat response; bevacizumab will be continued for one more cycle. If after two cycles on, there is no repeat response; bevacizumab will be continued with or without other standard chemotherapy until death. If after at least one cycle on, there is evidence of repeat response, bevacizumab will be discontinued for at least one cycle. In addition, the following will be performed: Bevacizumab will be given, physical examination and quality of life questionnaires will be performed and brain MRI.
Bevacizumab: Bevacizumab will be given at 10mg/kg IV every 2 weeks.
Optune: Optune will be worn continuously for 12 months. Optune is programmed by Novocure to deliver 200 kHz TTFields in two sequential, perpendicular field directions at a maximal intensity of 707mARMS. There will be no adjustments made to the device by investigators or patients/caregivers.
Brain MRI: Brain MRI will be done at screening and every 8 weeks.
Quality of Life Questionnaires: The quality of life questionnaires will be performed within 14 days of treatment and every 4 weeks.
|
|---|---|
|
Karnofsky Performance Scale
|
73.3 score on a scale
Standard Deviation 5.8
|
SECONDARY outcome
Timeframe: Assessed up to 24 monthsPopulation: participants completing at least 8 weeks of treatment with the Optune device with compliance rate \> 60% in at least one 4-week period.
The Mini Mental State Examination (MMSE) it is an 11-question measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall, and language. The maximum score is 30. The higher the score suggests less cognitive impairment. A score of 24-30 suggests no cognitive impairment. A score of 18-23 suggests mild cognitive impairment. A score of 0-17 suggests severe cognitive impairment. Patients are evaluable for assessment of QoL after completing at least 8 weeks of treatment with the Optune device with compliance rate \> 60% in at least one 4-week period.
Outcome measures
| Measure |
Optune+Pulsed Bevacizumab
n=3 Participants
The subjects will undergo 12 months of planned continuous treatment with Optune. The treatment will begin at week 0 and will be continuous throughout the study. Pulsed bevacizumab dosing is defined by at least one cycle on and at least one cycle off. A cycle is defined as 8 weeks in length. If after one cycle on, there is no evidence of a repeat response; bevacizumab will be continued for one more cycle. If after two cycles on, there is no repeat response; bevacizumab will be continued with or without other standard chemotherapy until death. If after at least one cycle on, there is evidence of repeat response, bevacizumab will be discontinued for at least one cycle. In addition, the following will be performed: Bevacizumab will be given, physical examination and quality of life questionnaires will be performed and brain MRI.
Bevacizumab: Bevacizumab will be given at 10mg/kg IV every 2 weeks.
Optune: Optune will be worn continuously for 12 months. Optune is programmed by Novocure to deliver 200 kHz TTFields in two sequential, perpendicular field directions at a maximal intensity of 707mARMS. There will be no adjustments made to the device by investigators or patients/caregivers.
Brain MRI: Brain MRI will be done at screening and every 8 weeks.
Quality of Life Questionnaires: The quality of life questionnaires will be performed within 14 days of treatment and every 4 weeks.
|
|---|---|
|
Mini-Mental Status Exam
|
23.2 score on a scale
Standard Deviation 5.1
|
SECONDARY outcome
Timeframe: Assessed up to 24 monthsPopulation: after completing at least 8 weeks of treatment with the Optune device with compliance rate \> 60% in at least one 4-week period.
The Response Assessment in Neuro-Oncology criteria were developed as an objective tool for radiologic assessment of treatment response in high-grade gliomas. Disease progression is defined as ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions (with the absolute increase of at least 1 dimension of at least 5 mm) compared with the smallest tumor measurement obtained either at baseline. Response assessment will be performed for patients completing at least 8 weeks of treatment with the Optune device with compliance rate \> 60% in at least one 4-week period.
Outcome measures
| Measure |
Optune+Pulsed Bevacizumab
n=3 Participants
The subjects will undergo 12 months of planned continuous treatment with Optune. The treatment will begin at week 0 and will be continuous throughout the study. Pulsed bevacizumab dosing is defined by at least one cycle on and at least one cycle off. A cycle is defined as 8 weeks in length. If after one cycle on, there is no evidence of a repeat response; bevacizumab will be continued for one more cycle. If after two cycles on, there is no repeat response; bevacizumab will be continued with or without other standard chemotherapy until death. If after at least one cycle on, there is evidence of repeat response, bevacizumab will be discontinued for at least one cycle. In addition, the following will be performed: Bevacizumab will be given, physical examination and quality of life questionnaires will be performed and brain MRI.
Bevacizumab: Bevacizumab will be given at 10mg/kg IV every 2 weeks.
Optune: Optune will be worn continuously for 12 months. Optune is programmed by Novocure to deliver 200 kHz TTFields in two sequential, perpendicular field directions at a maximal intensity of 707mARMS. There will be no adjustments made to the device by investigators or patients/caregivers.
Brain MRI: Brain MRI will be done at screening and every 8 weeks.
Quality of Life Questionnaires: The quality of life questionnaires will be performed within 14 days of treatment and every 4 weeks.
|
|---|---|
|
Response Assessment in Neuro-Oncology (RANO) Measurement Form
Progressive disease
|
2 Participants
|
|
Response Assessment in Neuro-Oncology (RANO) Measurement Form
Stable disease
|
1 Participants
|
Adverse Events
Optune+Pulsed Bevacizumab
Serious events: 4 serious events
Other events: 6 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Optune+Pulsed Bevacizumab
n=9 participants at risk
The subjects will undergo 12 months of planned continuous treatment with Optune. The treatment will begin at week 0 and will be continuous throughout the study. Pulsed bevacizumab dosing is defined by at least one cycle on and at least one cycle off. A cycle is defined as 8 weeks in length. If after one cycle on, there is no evidence of a repeat response; bevacizumab will be continued for one more cycle. If after two cycles on, there is no repeat response; bevacizumab will be continued with or without other standard chemotherapy until death. If after at least one cycle on, there is evidence of repeat response, bevacizumab will be discontinued for at least one cycle. In addition, the following will be performed: Bevacizumab will be given, physical examination and quality of life questionnaires will be performed and brain MRI.
Bevacizumab: Bevacizumab will be given at 10mg/kg IV every 2 weeks.
Optune: Optune will be worn continuously for 12 months. Optune is programmed by Novocure to deliver 200 kHz TTFields in two sequential, perpendicular field directions at a maximal intensity of 707mARMS. There will be no adjustments made to the device by investigators or patients/caregivers.
Brain MRI: Brain MRI will be done at screening and every 8 weeks.
Quality of Life Questionnaires: The quality of life questionnaires will be performed within 14 days of treatment and every 4 weeks.
|
|---|---|
|
General disorders
Non-cardiac chest pain
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from start of treatment with Optune and continuously throughout study treatment (up to 24 months) plus an additional 30 days post study completion or withdrawal for up to 25 months.
|
|
Vascular disorders
thromboembolic event
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from start of treatment with Optune and continuously throughout study treatment (up to 24 months) plus an additional 30 days post study completion or withdrawal for up to 25 months.
|
|
General disorders
Fatigue
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from start of treatment with Optune and continuously throughout study treatment (up to 24 months) plus an additional 30 days post study completion or withdrawal for up to 25 months.
|
|
Nervous system disorders
Headache
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from start of treatment with Optune and continuously throughout study treatment (up to 24 months) plus an additional 30 days post study completion or withdrawal for up to 25 months.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from start of treatment with Optune and continuously throughout study treatment (up to 24 months) plus an additional 30 days post study completion or withdrawal for up to 25 months.
|
|
Endocrine disorders
Hypothyroidism
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from start of treatment with Optune and continuously throughout study treatment (up to 24 months) plus an additional 30 days post study completion or withdrawal for up to 25 months.
|
|
Nervous system disorders
Seizure
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from start of treatment with Optune and continuously throughout study treatment (up to 24 months) plus an additional 30 days post study completion or withdrawal for up to 25 months.
|
|
Nervous system disorders
Nervous system disorder
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from start of treatment with Optune and continuously throughout study treatment (up to 24 months) plus an additional 30 days post study completion or withdrawal for up to 25 months.
|
Other adverse events
| Measure |
Optune+Pulsed Bevacizumab
n=9 participants at risk
The subjects will undergo 12 months of planned continuous treatment with Optune. The treatment will begin at week 0 and will be continuous throughout the study. Pulsed bevacizumab dosing is defined by at least one cycle on and at least one cycle off. A cycle is defined as 8 weeks in length. If after one cycle on, there is no evidence of a repeat response; bevacizumab will be continued for one more cycle. If after two cycles on, there is no repeat response; bevacizumab will be continued with or without other standard chemotherapy until death. If after at least one cycle on, there is evidence of repeat response, bevacizumab will be discontinued for at least one cycle. In addition, the following will be performed: Bevacizumab will be given, physical examination and quality of life questionnaires will be performed and brain MRI.
Bevacizumab: Bevacizumab will be given at 10mg/kg IV every 2 weeks.
Optune: Optune will be worn continuously for 12 months. Optune is programmed by Novocure to deliver 200 kHz TTFields in two sequential, perpendicular field directions at a maximal intensity of 707mARMS. There will be no adjustments made to the device by investigators or patients/caregivers.
Brain MRI: Brain MRI will be done at screening and every 8 weeks.
Quality of Life Questionnaires: The quality of life questionnaires will be performed within 14 days of treatment and every 4 weeks.
|
|---|---|
|
Psychiatric disorders
Confusion
|
44.4%
4/9 • Number of events 6 • Adverse events were collected from start of treatment with Optune and continuously throughout study treatment (up to 24 months) plus an additional 30 days post study completion or withdrawal for up to 25 months.
|
|
Psychiatric disorders
Anxiety
|
22.2%
2/9 • Number of events 6 • Adverse events were collected from start of treatment with Optune and continuously throughout study treatment (up to 24 months) plus an additional 30 days post study completion or withdrawal for up to 25 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
11.1%
1/9 • Number of events 4 • Adverse events were collected from start of treatment with Optune and continuously throughout study treatment (up to 24 months) plus an additional 30 days post study completion or withdrawal for up to 25 months.
|
|
Nervous system disorders
Seizure
|
55.6%
5/9 • Number of events 8 • Adverse events were collected from start of treatment with Optune and continuously throughout study treatment (up to 24 months) plus an additional 30 days post study completion or withdrawal for up to 25 months.
|
|
Psychiatric disorders
Depression
|
22.2%
2/9 • Number of events 4 • Adverse events were collected from start of treatment with Optune and continuously throughout study treatment (up to 24 months) plus an additional 30 days post study completion or withdrawal for up to 25 months.
|
|
General disorders
Fatigue
|
33.3%
3/9 • Number of events 3 • Adverse events were collected from start of treatment with Optune and continuously throughout study treatment (up to 24 months) plus an additional 30 days post study completion or withdrawal for up to 25 months.
|
|
Nervous system disorders
Memory impairment
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from start of treatment with Optune and continuously throughout study treatment (up to 24 months) plus an additional 30 days post study completion or withdrawal for up to 25 months.
|
|
Eye disorders
Blurred vision
|
11.1%
1/9 • Number of events 2 • Adverse events were collected from start of treatment with Optune and continuously throughout study treatment (up to 24 months) plus an additional 30 days post study completion or withdrawal for up to 25 months.
|
|
Nervous system disorders
Dysphasia
|
22.2%
2/9 • Number of events 2 • Adverse events were collected from start of treatment with Optune and continuously throughout study treatment (up to 24 months) plus an additional 30 days post study completion or withdrawal for up to 25 months.
|
|
Injury, poisoning and procedural complications
Fall
|
22.2%
2/9 • Number of events 3 • Adverse events were collected from start of treatment with Optune and continuously throughout study treatment (up to 24 months) plus an additional 30 days post study completion or withdrawal for up to 25 months.
|
|
Musculoskeletal and connective tissue disorders
Extremity pain
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from start of treatment with Optune and continuously throughout study treatment (up to 24 months) plus an additional 30 days post study completion or withdrawal for up to 25 months.
|
|
Vascular disorders
Thromboembolic event
|
11.1%
1/9 • Number of events 2 • Adverse events were collected from start of treatment with Optune and continuously throughout study treatment (up to 24 months) plus an additional 30 days post study completion or withdrawal for up to 25 months.
|
|
Nervous system disorders
Dizziness
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from start of treatment with Optune and continuously throughout study treatment (up to 24 months) plus an additional 30 days post study completion or withdrawal for up to 25 months.
|
|
Nervous system disorders
Dysarthria
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from start of treatment with Optune and continuously throughout study treatment (up to 24 months) plus an additional 30 days post study completion or withdrawal for up to 25 months.
|
|
Gastrointestinal disorders
Dyspepsia
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from start of treatment with Optune and continuously throughout study treatment (up to 24 months) plus an additional 30 days post study completion or withdrawal for up to 25 months.
|
|
General disorders
Edema
|
22.2%
2/9 • Number of events 2 • Adverse events were collected from start of treatment with Optune and continuously throughout study treatment (up to 24 months) plus an additional 30 days post study completion or withdrawal for up to 25 months.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from start of treatment with Optune and continuously throughout study treatment (up to 24 months) plus an additional 30 days post study completion or withdrawal for up to 25 months.
|
|
Nervous system disorders
Headache
|
22.2%
2/9 • Number of events 2 • Adverse events were collected from start of treatment with Optune and continuously throughout study treatment (up to 24 months) plus an additional 30 days post study completion or withdrawal for up to 25 months.
|
|
Psychiatric disorders
Insomnia
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from start of treatment with Optune and continuously throughout study treatment (up to 24 months) plus an additional 30 days post study completion or withdrawal for up to 25 months.
|
|
Nervous system disorders
Intracranial hemorrhage
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from start of treatment with Optune and continuously throughout study treatment (up to 24 months) plus an additional 30 days post study completion or withdrawal for up to 25 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from start of treatment with Optune and continuously throughout study treatment (up to 24 months) plus an additional 30 days post study completion or withdrawal for up to 25 months.
|
|
Nervous system disorders
Paresthesia
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from start of treatment with Optune and continuously throughout study treatment (up to 24 months) plus an additional 30 days post study completion or withdrawal for up to 25 months.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from start of treatment with Optune and continuously throughout study treatment (up to 24 months) plus an additional 30 days post study completion or withdrawal for up to 25 months.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
11.1%
1/9 • Number of events 2 • Adverse events were collected from start of treatment with Optune and continuously throughout study treatment (up to 24 months) plus an additional 30 days post study completion or withdrawal for up to 25 months.
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from start of treatment with Optune and continuously throughout study treatment (up to 24 months) plus an additional 30 days post study completion or withdrawal for up to 25 months.
|
|
General disorders
Pain
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from start of treatment with Optune and continuously throughout study treatment (up to 24 months) plus an additional 30 days post study completion or withdrawal for up to 25 months.
|
|
Renal and urinary disorders
Proteinuria
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from start of treatment with Optune and continuously throughout study treatment (up to 24 months) plus an additional 30 days post study completion or withdrawal for up to 25 months.
|
|
Vascular disorders
Hypertension
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from start of treatment with Optune and continuously throughout study treatment (up to 24 months) plus an additional 30 days post study completion or withdrawal for up to 25 months.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from start of treatment with Optune and continuously throughout study treatment (up to 24 months) plus an additional 30 days post study completion or withdrawal for up to 25 months.
|
|
Injury, poisoning and procedural complications
Fracture
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from start of treatment with Optune and continuously throughout study treatment (up to 24 months) plus an additional 30 days post study completion or withdrawal for up to 25 months.
|
|
Investigations
Platelet count decreased
|
11.1%
1/9 • Number of events 2 • Adverse events were collected from start of treatment with Optune and continuously throughout study treatment (up to 24 months) plus an additional 30 days post study completion or withdrawal for up to 25 months.
|
|
Nervous system disorders
Nervous System Disorder
|
22.2%
2/9 • Number of events 3 • Adverse events were collected from start of treatment with Optune and continuously throughout study treatment (up to 24 months) plus an additional 30 days post study completion or withdrawal for up to 25 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place