Trial Outcomes & Findings for Effect of Tumor Treating Fields (TTFields) (150 kHz) Concurrent With Standard of Care Therapies for Treatment of Stage 4 Non-small Cell Lung Cancer (NSCLC) Following Platinum Failure (LUNAR) (NCT NCT02973789)
NCT ID: NCT02973789
Last Updated: 2026-03-18
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
291 participants
Primary outcome timeframe
From date of randomization until the date of death from any cause, assessed up to 12 month after the last participant was enrolled (median duration of follow-up was 10.0 months).
Results posted on
2026-03-18
Participant Flow
Participant milestones
| Measure |
TTFields + Standard of Care
TTFields were to be delivered for at least 18 hours per day on a monthly average until disease progression in the thorax and/or the liver or intolerable toxicity. Standard of care treatment was administered until disease progression or intolerable toxicity: Immune checkpoint inhibitor (Nivolumab - 240 mg every 2 weeks or 480 mg every 4 weeks or as a weight-based dose, Pembrolizumab - 200 mg every 3 weeks or 400 mg every 6 weeks, or as a weight-based dose, Atezolizumab - 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks) OR docetaxel (75 mg/m2 IV over 1 hour every 3 weeks).
|
Standard of Care
Standard of care treatment was administered until disease progression or intolerable toxicity: Immune checkpoint inhibitor (Nivolumab - 240 mg every 2 weeks or 480 mg every 4 weeks or as a weight-based dose, or Pembrolizumab - 200 mg every 3 weeks or 400 mg every 6 weeks, or as a weight-based dose, or Atezolizumab - 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks) OR docetaxel (75 mg/m2 IV over 1 hour every 3 weeks).
|
|---|---|---|
|
Overall Study
STARTED
|
145
|
146
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
145
|
146
|
Reasons for withdrawal
| Measure |
TTFields + Standard of Care
TTFields were to be delivered for at least 18 hours per day on a monthly average until disease progression in the thorax and/or the liver or intolerable toxicity. Standard of care treatment was administered until disease progression or intolerable toxicity: Immune checkpoint inhibitor (Nivolumab - 240 mg every 2 weeks or 480 mg every 4 weeks or as a weight-based dose, Pembrolizumab - 200 mg every 3 weeks or 400 mg every 6 weeks, or as a weight-based dose, Atezolizumab - 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks) OR docetaxel (75 mg/m2 IV over 1 hour every 3 weeks).
|
Standard of Care
Standard of care treatment was administered until disease progression or intolerable toxicity: Immune checkpoint inhibitor (Nivolumab - 240 mg every 2 weeks or 480 mg every 4 weeks or as a weight-based dose, or Pembrolizumab - 200 mg every 3 weeks or 400 mg every 6 weeks, or as a weight-based dose, or Atezolizumab - 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks) OR docetaxel (75 mg/m2 IV over 1 hour every 3 weeks).
|
|---|---|---|
|
Overall Study
Death
|
100
|
101
|
|
Overall Study
Lost to Follow-up
|
3
|
4
|
|
Overall Study
Withdrawal by Subject
|
18
|
19
|
|
Overall Study
Other
|
24
|
22
|
Baseline Characteristics
Effect of Tumor Treating Fields (TTFields) (150 kHz) Concurrent With Standard of Care Therapies for Treatment of Stage 4 Non-small Cell Lung Cancer (NSCLC) Following Platinum Failure (LUNAR)
Baseline characteristics by cohort
| Measure |
TTFields + Standard of Care
n=145 Participants
TTFields were to be delivered for at least 18 hours per day on a monthly average until disease progression in the thorax and/or the liver or intolerable toxicity. Standard of care treatment was administered until disease progression or intolerable toxicity: Immune checkpoint inhibitor (Nivolumab - 240 mg every 2 weeks or 480 mg every 4 weeks or as a weight-based dose, Pembrolizumab - 200 mg every 3 weeks or 400 mg every 6 weeks, or as a weight-based dose, Atezolizumab - 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks) OR docetaxel (75 mg/m2 IV over 1 hour every 3 weeks).
|
Standard of Care
n=146 Participants
Standard of care treatment was administered until disease progression or intolerable toxicity: Immune checkpoint inhibitor (Nivolumab - 240 mg every 2 weeks or 480 mg every 4 weeks or as a weight-based dose, or Pembrolizumab - 200 mg every 3 weeks or 400 mg every 6 weeks, or as a weight-based dose, or Atezolizumab - 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks) OR docetaxel (75 mg/m2 IV over 1 hour every 3 weeks).
|
Total
n=291 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Smoking History
Unknown
|
1 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
1 Participants
n=224 Participants
|
|
Age, Continuous
|
64 Years
n=110 Participants
|
65 Years
n=114 Participants
|
65 Years
n=224 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=110 Participants
|
54 Participants
n=114 Participants
|
100 Participants
n=224 Participants
|
|
Sex: Female, Male
Male
|
99 Participants
n=110 Participants
|
92 Participants
n=114 Participants
|
191 Participants
n=224 Participants
|
|
ECOG Performance Status
Score 0
|
41 Participants
n=110 Participants
|
41 Participants
n=114 Participants
|
82 Participants
n=224 Participants
|
|
ECOG Performance Status
Score 1
|
97 Participants
n=110 Participants
|
101 Participants
n=114 Participants
|
198 Participants
n=224 Participants
|
|
ECOG Performance Status
Score 2
|
7 Participants
n=110 Participants
|
4 Participants
n=114 Participants
|
11 Participants
n=224 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
0 Participants
n=110 Participants
|
2 Participants
n=114 Participants
|
2 Participants
n=224 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
19 Participants
n=110 Participants
|
17 Participants
n=114 Participants
|
36 Participants
n=224 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
4 Participants
n=110 Participants
|
3 Participants
n=114 Participants
|
7 Participants
n=224 Participants
|
|
Race/Ethnicity, Customized
Race · Pacific Islander
|
1 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
1 Participants
n=224 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
115 Participants
n=110 Participants
|
113 Participants
n=114 Participants
|
228 Participants
n=224 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
5 Participants
n=110 Participants
|
8 Participants
n=114 Participants
|
13 Participants
n=224 Participants
|
|
Race/Ethnicity, Customized
Race · Missing
|
1 Participants
n=110 Participants
|
3 Participants
n=114 Participants
|
4 Participants
n=224 Participants
|
|
Smoking History
Never smoked
|
20 Participants
n=110 Participants
|
24 Participants
n=114 Participants
|
44 Participants
n=224 Participants
|
|
Smoking History
Current smoker
|
36 Participants
n=110 Participants
|
30 Participants
n=114 Participants
|
66 Participants
n=224 Participants
|
|
Smoking History
Former smoker
|
88 Participants
n=110 Participants
|
92 Participants
n=114 Participants
|
180 Participants
n=224 Participants
|
|
Region of Enrollment
North America
|
44 Participants
n=110 Participants
|
43 Participants
n=114 Participants
|
87 Participants
n=224 Participants
|
|
Region of Enrollment
Western Europe and Israel
|
42 Participants
n=110 Participants
|
41 Participants
n=114 Participants
|
83 Participants
n=224 Participants
|
|
Region of Enrollment
Eastern Europe
|
43 Participants
n=110 Participants
|
45 Participants
n=114 Participants
|
88 Participants
n=224 Participants
|
|
Region of Enrollment
East Asia
|
16 Participants
n=110 Participants
|
17 Participants
n=114 Participants
|
33 Participants
n=224 Participants
|
|
Tumor Histology
Non-Squamous
|
83 Participants
n=110 Participants
|
82 Participants
n=114 Participants
|
165 Participants
n=224 Participants
|
|
Tumor Histology
Squamous
|
62 Participants
n=110 Participants
|
64 Participants
n=114 Participants
|
126 Participants
n=224 Participants
|
PRIMARY outcome
Timeframe: From date of randomization until the date of death from any cause, assessed up to 12 month after the last participant was enrolled (median duration of follow-up was 10.0 months).Outcome measures
| Measure |
TTFields + Standard of Care
n=145 Participants
TTFields were to be delivered for at least 18 hours per day on a monthly average until disease progression in the thorax and/or the liver or intolerable toxicity. Standard of care treatment was administered until disease progression or intolerable toxicity: Immune checkpoint inhibitor (Nivolumab - 240 mg every 2 weeks or 480 mg every 4 weeks or as a weight-based dose, Pembrolizumab - 200 mg every 3 weeks or 400 mg every 6 weeks, or as a weight-based dose, Atezolizumab - 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks) OR docetaxel (75 mg/m2 IV over 1 hour every 3 weeks).
|
Standard of Care
n=146 Participants
Standard of care treatment was administered until disease progression or intolerable toxicity: Immune checkpoint inhibitor (Nivolumab - 240 mg every 2 weeks or 480 mg every 4 weeks or as a weight-based dose, or Pembrolizumab - 200 mg every 3 weeks or 400 mg every 6 weeks, or as a weight-based dose, or Atezolizumab - 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks) OR docetaxel (75 mg/m2 IV over 1 hour every 3 weeks).
|
|---|---|---|
|
Overall Survival of Patients Treated With TTFields + Docetaxel or Immune Checkpoint Inhibitors vs. Docetaxel or Immune Checkpoint Inhibitors Alone (Superiority Analysis)
|
13.2 Months
Interval 10.3 to 15.5
|
9.9 Months
Interval 8.2 to 12.2
|
SECONDARY outcome
Timeframe: From date of randomization until the date of death from any cause, assessed up to 12 month after the last participant was enrolled (median duration of follow-up was 10.6 months).Outcome measures
| Measure |
TTFields + Standard of Care
n=70 Participants
TTFields were to be delivered for at least 18 hours per day on a monthly average until disease progression in the thorax and/or the liver or intolerable toxicity. Standard of care treatment was administered until disease progression or intolerable toxicity: Immune checkpoint inhibitor (Nivolumab - 240 mg every 2 weeks or 480 mg every 4 weeks or as a weight-based dose, Pembrolizumab - 200 mg every 3 weeks or 400 mg every 6 weeks, or as a weight-based dose, Atezolizumab - 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks) OR docetaxel (75 mg/m2 IV over 1 hour every 3 weeks).
|
Standard of Care
n=71 Participants
Standard of care treatment was administered until disease progression or intolerable toxicity: Immune checkpoint inhibitor (Nivolumab - 240 mg every 2 weeks or 480 mg every 4 weeks or as a weight-based dose, or Pembrolizumab - 200 mg every 3 weeks or 400 mg every 6 weeks, or as a weight-based dose, or Atezolizumab - 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks) OR docetaxel (75 mg/m2 IV over 1 hour every 3 weeks).
|
|---|---|---|
|
Overall Survival of Patients Treated With TTFields + Immune Checkpoint Inhibitors vs. Immune Checkpoint Inhibitors Alone (Superiority)
|
19.0 Months
Interval 10.6 to 28.2
|
10.8 Months
Interval 8.3 to 17.6
|
SECONDARY outcome
Timeframe: From date of randomization until the date of death from any cause, assessed up to 12 month after the last participant was enrolled (median duration of follow-up was 9.7 months).Outcome measures
| Measure |
TTFields + Standard of Care
n=75 Participants
TTFields were to be delivered for at least 18 hours per day on a monthly average until disease progression in the thorax and/or the liver or intolerable toxicity. Standard of care treatment was administered until disease progression or intolerable toxicity: Immune checkpoint inhibitor (Nivolumab - 240 mg every 2 weeks or 480 mg every 4 weeks or as a weight-based dose, Pembrolizumab - 200 mg every 3 weeks or 400 mg every 6 weeks, or as a weight-based dose, Atezolizumab - 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks) OR docetaxel (75 mg/m2 IV over 1 hour every 3 weeks).
|
Standard of Care
n=75 Participants
Standard of care treatment was administered until disease progression or intolerable toxicity: Immune checkpoint inhibitor (Nivolumab - 240 mg every 2 weeks or 480 mg every 4 weeks or as a weight-based dose, or Pembrolizumab - 200 mg every 3 weeks or 400 mg every 6 weeks, or as a weight-based dose, or Atezolizumab - 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks) OR docetaxel (75 mg/m2 IV over 1 hour every 3 weeks).
|
|---|---|---|
|
Overall Survival of Patients Treated With TTFields + Docetaxel vs. Docetaxel Alone (Superiority Analysis)
|
11.1 Months
Interval 8.2 to 13.9
|
8.9 Months
Interval 6.5 to 11.3
|
SECONDARY outcome
Timeframe: From date of randomization until the date of death from any cause, assessed up to 12 month after the last participant was enrolled. (median duration of follow-up was 10.1 months)Outcome measures
| Measure |
TTFields + Standard of Care
n=75 Participants
TTFields were to be delivered for at least 18 hours per day on a monthly average until disease progression in the thorax and/or the liver or intolerable toxicity. Standard of care treatment was administered until disease progression or intolerable toxicity: Immune checkpoint inhibitor (Nivolumab - 240 mg every 2 weeks or 480 mg every 4 weeks or as a weight-based dose, Pembrolizumab - 200 mg every 3 weeks or 400 mg every 6 weeks, or as a weight-based dose, Atezolizumab - 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks) OR docetaxel (75 mg/m2 IV over 1 hour every 3 weeks).
|
Standard of Care
n=71 Participants
Standard of care treatment was administered until disease progression or intolerable toxicity: Immune checkpoint inhibitor (Nivolumab - 240 mg every 2 weeks or 480 mg every 4 weeks or as a weight-based dose, or Pembrolizumab - 200 mg every 3 weeks or 400 mg every 6 weeks, or as a weight-based dose, or Atezolizumab - 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks) OR docetaxel (75 mg/m2 IV over 1 hour every 3 weeks).
|
|---|---|---|
|
Overall Survival of Patients Treated With TTFields + Docetaxel Vs. Immune Checkpoint Inhibitors Alone (Non-inferiority Analysis)
|
11.1 Months
Interval 8.2 to 13.9
|
10.8 Months
Interval 8.3 to 17.6
|
SECONDARY outcome
Timeframe: From date of randomization until the date of disease progression according to RECIST criteria, assessed up to 12 month after the last participant was enrolled (median duration of follow-up was 10.0 months, maximal follow-up duration was 64.4 months).Outcome measures
| Measure |
TTFields + Standard of Care
n=145 Participants
TTFields were to be delivered for at least 18 hours per day on a monthly average until disease progression in the thorax and/or the liver or intolerable toxicity. Standard of care treatment was administered until disease progression or intolerable toxicity: Immune checkpoint inhibitor (Nivolumab - 240 mg every 2 weeks or 480 mg every 4 weeks or as a weight-based dose, Pembrolizumab - 200 mg every 3 weeks or 400 mg every 6 weeks, or as a weight-based dose, Atezolizumab - 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks) OR docetaxel (75 mg/m2 IV over 1 hour every 3 weeks).
|
Standard of Care
n=146 Participants
Standard of care treatment was administered until disease progression or intolerable toxicity: Immune checkpoint inhibitor (Nivolumab - 240 mg every 2 weeks or 480 mg every 4 weeks or as a weight-based dose, or Pembrolizumab - 200 mg every 3 weeks or 400 mg every 6 weeks, or as a weight-based dose, or Atezolizumab - 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks) OR docetaxel (75 mg/m2 IV over 1 hour every 3 weeks).
|
|---|---|---|
|
Progression-free Survival of Patients Treated With Docetaxel or Immune Checkpoint Inhibitors + TTFields vs. Docetaxel or Immune Checkpoint Inhibitors Alone, Based on RECIST Criteria
|
4.4 Months
Interval 4.1 to 5.7
|
4.2 Months
Interval 3.5 to 4.7
|
SECONDARY outcome
Timeframe: From date of randomization until the date of disease progression according to RECIST criteria, assessed up to 12 month after the last participant was enrolled (median duration of follow-up was 4.2 months, maximal follow-up duration was 64.4 months).Outcome measures
| Measure |
TTFields + Standard of Care
n=145 Participants
TTFields were to be delivered for at least 18 hours per day on a monthly average until disease progression in the thorax and/or the liver or intolerable toxicity. Standard of care treatment was administered until disease progression or intolerable toxicity: Immune checkpoint inhibitor (Nivolumab - 240 mg every 2 weeks or 480 mg every 4 weeks or as a weight-based dose, Pembrolizumab - 200 mg every 3 weeks or 400 mg every 6 weeks, or as a weight-based dose, Atezolizumab - 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks) OR docetaxel (75 mg/m2 IV over 1 hour every 3 weeks).
|
Standard of Care
n=146 Participants
Standard of care treatment was administered until disease progression or intolerable toxicity: Immune checkpoint inhibitor (Nivolumab - 240 mg every 2 weeks or 480 mg every 4 weeks or as a weight-based dose, or Pembrolizumab - 200 mg every 3 weeks or 400 mg every 6 weeks, or as a weight-based dose, or Atezolizumab - 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks) OR docetaxel (75 mg/m2 IV over 1 hour every 3 weeks).
|
|---|---|---|
|
Overall Radiological Response Rate (Based on RECIST Criteria) of Patients Treated With Docetaxel or Immune Checkpoint Inhibitors + TTFields vs. Docetaxel or Immune Checkpoint Inhibitors Alone.
|
28 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: From baseline up to 54 weeksPopulation: Number of participants with both baseline and follow-up data
Quality of life was assessed using the EORTC QLQ-C30 and EORTC QLQ-LC13. QLQ-C30 includes global health status; five functioning scales (physical, role, emotional, cognitive, social); three symptom scales (fatigue, pain, nausea/vomiting); and single-item symptoms (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). QLQ-LC13 includes 13 lung cancer-specific symptom/treatment items. All scores are transformed to 0-100 per EORTC scoring. For global health and all functioning scales, higher scores indicate better quality of life (0 worst, 100 best). For all symptom scales/items in QLQ-C30 and all QLQ-LC13 measures, higher scores indicate greater symptom burden (0 best, 100 worst). Change from baseline = Week 54 minus baseline; positive change indicates improvement for global health/functioning and worsening for symptoms. A \>10-point change was considered clinically meaningful.
Outcome measures
| Measure |
TTFields + Standard of Care
n=145 Participants
TTFields were to be delivered for at least 18 hours per day on a monthly average until disease progression in the thorax and/or the liver or intolerable toxicity. Standard of care treatment was administered until disease progression or intolerable toxicity: Immune checkpoint inhibitor (Nivolumab - 240 mg every 2 weeks or 480 mg every 4 weeks or as a weight-based dose, Pembrolizumab - 200 mg every 3 weeks or 400 mg every 6 weeks, or as a weight-based dose, Atezolizumab - 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks) OR docetaxel (75 mg/m2 IV over 1 hour every 3 weeks).
|
Standard of Care
n=146 Participants
Standard of care treatment was administered until disease progression or intolerable toxicity: Immune checkpoint inhibitor (Nivolumab - 240 mg every 2 weeks or 480 mg every 4 weeks or as a weight-based dose, or Pembrolizumab - 200 mg every 3 weeks or 400 mg every 6 weeks, or as a weight-based dose, or Atezolizumab - 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks) OR docetaxel (75 mg/m2 IV over 1 hour every 3 weeks).
|
|---|---|---|
|
Quality of Life Using the EORTC QLQ C30 Questionnaire With LC13 Addendum
EORTC QLQ C-30 - Global health status / QoL
|
0.0 Score
Standard Deviation 20.8
|
7.9 Score
Standard Deviation 22.0
|
|
Quality of Life Using the EORTC QLQ C30 Questionnaire With LC13 Addendum
EORTC QLQ C-30 - Physical functioning
|
-8.0 Score
Standard Deviation 18.4
|
2.2 Score
Standard Deviation 20.1
|
|
Quality of Life Using the EORTC QLQ C30 Questionnaire With LC13 Addendum
EORTC QLQ C-30 - Role functioning
|
-12.5 Score
Standard Deviation 19.4
|
5.8 Score
Standard Deviation 30.2
|
|
Quality of Life Using the EORTC QLQ C30 Questionnaire With LC13 Addendum
EORTC QLQ C-30 - Emotional functioning
|
-4.2 Score
Standard Deviation 17.0
|
1.8 Score
Standard Deviation 21.6
|
|
Quality of Life Using the EORTC QLQ C30 Questionnaire With LC13 Addendum
EORTC QLQ C-30 - Cognitive functioning
|
-10.0 Score
Standard Deviation 17.4
|
-0.9 Score
Standard Deviation 10.3
|
|
Quality of Life Using the EORTC QLQ C30 Questionnaire With LC13 Addendum
EORTC QLQ C-30 - Social functioning
|
-16.7 Score
Standard Deviation 27.6
|
-2.6 Score
Standard Deviation 21.7
|
|
Quality of Life Using the EORTC QLQ C30 Questionnaire With LC13 Addendum
EORTC QLQ C-30 - Fatigue
|
2.8 Score
Standard Deviation 24.1
|
1.1 Score
Standard Deviation 23.6
|
|
Quality of Life Using the EORTC QLQ C30 Questionnaire With LC13 Addendum
EORTC QLQ C-30 - Nausea and vomiting
|
0.0 Score
Standard Deviation 10.8
|
3.3 Score
Standard Deviation 6.8
|
|
Quality of Life Using the EORTC QLQ C30 Questionnaire With LC13 Addendum
EORTC QLQ C-30 - Pain
|
-5.0 Score
Standard Deviation 23.0
|
-2.5 Score
Standard Deviation 14.6
|
|
Quality of Life Using the EORTC QLQ C30 Questionnaire With LC13 Addendum
EORTC QLQ C-30 - Dyspnea
|
-6.7 Score
Standard Deviation 27.8
|
-1.7 Score
Standard Deviation 29.6
|
|
Quality of Life Using the EORTC QLQ C30 Questionnaire With LC13 Addendum
EORTC QLQ C-30 - Insomnia
|
3.3 Score
Standard Deviation 26.7
|
-8.3 Score
Standard Deviation 18.3
|
|
Quality of Life Using the EORTC QLQ C30 Questionnaire With LC13 Addendum
EORTC QLQ C-30 - Appetite loss
|
1.7 Score
Standard Deviation 22.9
|
-1.7 Score
Standard Deviation 42.5
|
|
Quality of Life Using the EORTC QLQ C30 Questionnaire With LC13 Addendum
EORTC QLQ C-30 - Constipation
|
-3.3 Score
Standard Deviation 28.4
|
-8.3 Score
Standard Deviation 21.3
|
|
Quality of Life Using the EORTC QLQ C30 Questionnaire With LC13 Addendum
EORTC QLQ C-30 - Diarrhea
|
6.7 Score
Standard Deviation 17.4
|
0.0 Score
Standard Deviation 22.2
|
|
Quality of Life Using the EORTC QLQ C30 Questionnaire With LC13 Addendum
EORTC QLQ C-30 - Financial difficulties
|
1.7 Score
Standard Deviation 38.2
|
-3.5 Score
Standard Deviation 31.2
|
|
Quality of Life Using the EORTC QLQ C30 Questionnaire With LC13 Addendum
EORTC QLQ LC-13 - Cough
|
-8.3 Score
Standard Deviation 21.3
|
0.0 Score
Standard Deviation 34.2
|
|
Quality of Life Using the EORTC QLQ C30 Questionnaire With LC13 Addendum
EORTC QLQ LC-13 - Haemoptysis
|
-1.7 Score
Standard Deviation 7.4
|
0.0 Score
Standard Deviation 0.0
|
|
Quality of Life Using the EORTC QLQ C30 Questionnaire With LC13 Addendum
EORTC QLQ LC-13 - Sore mouth or tongue
|
3.3 Score
Standard Deviation 18.4
|
1.7 Score
Standard Deviation 22.9
|
|
Quality of Life Using the EORTC QLQ C30 Questionnaire With LC13 Addendum
EORTC QLQ LC-13 - Dysphagia
|
-3.3 Score
Standard Deviation 14.9
|
0.0 Score
Standard Deviation 21.6
|
|
Quality of Life Using the EORTC QLQ C30 Questionnaire With LC13 Addendum
EORTC QLQ LC-13 - Peripheral neuropathy
|
6.7 Score
Standard Deviation 23.2
|
5.0 Score
Standard Deviation 24.8
|
|
Quality of Life Using the EORTC QLQ C30 Questionnaire With LC13 Addendum
EORTC QLQ LC-13 - Alopecia
|
-16.7 Score
Standard Deviation 33.3
|
5.0 Score
Standard Deviation 36.3
|
|
Quality of Life Using the EORTC QLQ C30 Questionnaire With LC13 Addendum
EORTC QLQ LC-13 - Pain in chest
|
5.0 Score
Standard Deviation 16.3
|
0.0 Score
Standard Deviation 10.8
|
|
Quality of Life Using the EORTC QLQ C30 Questionnaire With LC13 Addendum
EORTC QLQ LC-13 - Pain in arm or shoulder
|
-3.3 Score
Standard Deviation 21.4
|
0.0 Score
Standard Deviation 15.3
|
|
Quality of Life Using the EORTC QLQ C30 Questionnaire With LC13 Addendum
EORTC QLQ LC-13 - Pain in other parts
|
3.3 Score
Standard Deviation 28.4
|
8.8 Score
Standard Deviation 29.1
|
|
Quality of Life Using the EORTC QLQ C30 Questionnaire With LC13 Addendum
EORTC QLQ LC-13 - Dyspnoea
|
3.3 Score
Standard Deviation 23.9
|
-7.2 Score
Standard Deviation 25.6
|
SECONDARY outcome
Timeframe: From date of randomization until the date of death from any cause (OS), or until date of disease progression according to RECIST criteria (PFS) , assessed up to 12 month after last participant enrolled (median duration of follow-up 10.7 months).Population: Each analysis include the participants received the applicable checkpoint inhibitor
Outcome measures
| Measure |
TTFields + Standard of Care
n=70 Participants
TTFields were to be delivered for at least 18 hours per day on a monthly average until disease progression in the thorax and/or the liver or intolerable toxicity. Standard of care treatment was administered until disease progression or intolerable toxicity: Immune checkpoint inhibitor (Nivolumab - 240 mg every 2 weeks or 480 mg every 4 weeks or as a weight-based dose, Pembrolizumab - 200 mg every 3 weeks or 400 mg every 6 weeks, or as a weight-based dose, Atezolizumab - 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks) OR docetaxel (75 mg/m2 IV over 1 hour every 3 weeks).
|
Standard of Care
n=68 Participants
Standard of care treatment was administered until disease progression or intolerable toxicity: Immune checkpoint inhibitor (Nivolumab - 240 mg every 2 weeks or 480 mg every 4 weeks or as a weight-based dose, or Pembrolizumab - 200 mg every 3 weeks or 400 mg every 6 weeks, or as a weight-based dose, or Atezolizumab - 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks) OR docetaxel (75 mg/m2 IV over 1 hour every 3 weeks).
|
|---|---|---|
|
Analyses of the Effects of NovoTTF-200T With Each Type of Immune Checkpoint Inhibitor on Overall Survival and Progression Free Survival
Atezolizumab OS
|
46.9 Months
Interval 9.8 to
Not reached
|
12.7 Months
Interval 7.2 to 22.2
|
|
Analyses of the Effects of NovoTTF-200T With Each Type of Immune Checkpoint Inhibitor on Overall Survival and Progression Free Survival
Nivolumab OS
|
18.5 Months
Interval 8.8 to 28.2
|
10.0 Months
Interval 6.9 to 17.6
|
|
Analyses of the Effects of NovoTTF-200T With Each Type of Immune Checkpoint Inhibitor on Overall Survival and Progression Free Survival
Pembrolizumab OS
|
23.6 Months
Interval 1.81 to
Not reached
|
30.0 Months
Interval 1.41 to
Not reached
|
|
Analyses of the Effects of NovoTTF-200T With Each Type of Immune Checkpoint Inhibitor on Overall Survival and Progression Free Survival
Atezolizumab PFS
|
9.3 Months
Interval 1.9 to 17.9
|
4.1 Months
Interval 1.7 to 5.3
|
|
Analyses of the Effects of NovoTTF-200T With Each Type of Immune Checkpoint Inhibitor on Overall Survival and Progression Free Survival
Nivolumab PFS
|
4.4 Months
Interval 3.0 to 9.4
|
3.2 Months
Interval 1.5 to 8.2
|
|
Analyses of the Effects of NovoTTF-200T With Each Type of Immune Checkpoint Inhibitor on Overall Survival and Progression Free Survival
Pembrolizumab PFS
|
11.2 Months
Interval 1.2 to
Not reached
|
11.2 Months
Interval 1.4 to
Not reached
|
SECONDARY outcome
Timeframe: From date of randomization until the date of death from any cause (OS), or until date of disease progression according to RECIST criteria (PFS) , assessed up to 12 month after last participant enrolled (median duration of follow-up 10.0 months).Population: Each analysis include the participants with the applicable histology
Outcome measures
| Measure |
TTFields + Standard of Care
n=145 Participants
TTFields were to be delivered for at least 18 hours per day on a monthly average until disease progression in the thorax and/or the liver or intolerable toxicity. Standard of care treatment was administered until disease progression or intolerable toxicity: Immune checkpoint inhibitor (Nivolumab - 240 mg every 2 weeks or 480 mg every 4 weeks or as a weight-based dose, Pembrolizumab - 200 mg every 3 weeks or 400 mg every 6 weeks, or as a weight-based dose, Atezolizumab - 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks) OR docetaxel (75 mg/m2 IV over 1 hour every 3 weeks).
|
Standard of Care
n=146 Participants
Standard of care treatment was administered until disease progression or intolerable toxicity: Immune checkpoint inhibitor (Nivolumab - 240 mg every 2 weeks or 480 mg every 4 weeks or as a weight-based dose, or Pembrolizumab - 200 mg every 3 weeks or 400 mg every 6 weeks, or as a weight-based dose, or Atezolizumab - 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks) OR docetaxel (75 mg/m2 IV over 1 hour every 3 weeks).
|
|---|---|---|
|
Analysis of the Effects of NovoTTF-200T on Overall Survival and Progression Free Survival Within Each Histological Subgroup (Squamous and Non-squamous)
Squamous histology OS
|
13.9 Months
Interval 9.7 to 17.1
|
10.1 Months
Interval 8.3 to 14.3
|
|
Analysis of the Effects of NovoTTF-200T on Overall Survival and Progression Free Survival Within Each Histological Subgroup (Squamous and Non-squamous)
Non-squamous histology PFS
|
5.3 Months
Interval 3.9 to 5.9
|
4.0 Months
Interval 2.7 to 4.3
|
|
Analysis of the Effects of NovoTTF-200T on Overall Survival and Progression Free Survival Within Each Histological Subgroup (Squamous and Non-squamous)
Squamous histology PFS
|
4.2 Months
Interval 2.8 to 5.7
|
4.9 Months
Interval 3.9 to 6.0
|
|
Analysis of the Effects of NovoTTF-200T on Overall Survival and Progression Free Survival Within Each Histological Subgroup (Squamous and Non-squamous)
Non-squamous histology OS
|
13.2 Months
Interval 8.7 to 19.8
|
9.9 Months
Interval 7.1 to 15.3
|
SECONDARY outcome
Timeframe: From date of randomization until the date of death from any cause (OS), or until date of disease progression according to RECIST criteria (PFS) , assessed up to 12 month after last participant enrolled (median duration of follow-up 10.7 months).Population: 141 participants enrolled in the TTFields therapy arm had available usage data.
Outcome measures
| Measure |
TTFields + Standard of Care
n=32 Participants
TTFields were to be delivered for at least 18 hours per day on a monthly average until disease progression in the thorax and/or the liver or intolerable toxicity. Standard of care treatment was administered until disease progression or intolerable toxicity: Immune checkpoint inhibitor (Nivolumab - 240 mg every 2 weeks or 480 mg every 4 weeks or as a weight-based dose, Pembrolizumab - 200 mg every 3 weeks or 400 mg every 6 weeks, or as a weight-based dose, Atezolizumab - 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks) OR docetaxel (75 mg/m2 IV over 1 hour every 3 weeks).
|
Standard of Care
n=109 Participants
Standard of care treatment was administered until disease progression or intolerable toxicity: Immune checkpoint inhibitor (Nivolumab - 240 mg every 2 weeks or 480 mg every 4 weeks or as a weight-based dose, or Pembrolizumab - 200 mg every 3 weeks or 400 mg every 6 weeks, or as a weight-based dose, or Atezolizumab - 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks) OR docetaxel (75 mg/m2 IV over 1 hour every 3 weeks).
|
|---|---|---|
|
The Effect of Treatment Compliance With NovoTTF-200T on Overall Survival and Progression Free Survival Outcomes
|
32 Participants
|
109 Participants
|
SECONDARY outcome
Timeframe: From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).Population: Analysis included all patients who received the interventional therapy - 141 patients from each of the study arms. Patients with AE by Maximum CTCAE Grade are presented (Grade 1 is a mild AE, while grade 5 results in death).
Outcome measures
| Measure |
TTFields + Standard of Care
n=141 Participants
TTFields were to be delivered for at least 18 hours per day on a monthly average until disease progression in the thorax and/or the liver or intolerable toxicity. Standard of care treatment was administered until disease progression or intolerable toxicity: Immune checkpoint inhibitor (Nivolumab - 240 mg every 2 weeks or 480 mg every 4 weeks or as a weight-based dose, Pembrolizumab - 200 mg every 3 weeks or 400 mg every 6 weeks, or as a weight-based dose, Atezolizumab - 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks) OR docetaxel (75 mg/m2 IV over 1 hour every 3 weeks).
|
Standard of Care
n=141 Participants
Standard of care treatment was administered until disease progression or intolerable toxicity: Immune checkpoint inhibitor (Nivolumab - 240 mg every 2 weeks or 480 mg every 4 weeks or as a weight-based dose, or Pembrolizumab - 200 mg every 3 weeks or 400 mg every 6 weeks, or as a weight-based dose, or Atezolizumab - 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks) OR docetaxel (75 mg/m2 IV over 1 hour every 3 weeks).
|
|---|---|---|
|
Adverse Events, Severity and Frequency Based on Common Terminology Criteria for Adverse Events (CTCAE) V4.03
Grade 1
|
15 Participants
|
23 Participants
|
|
Adverse Events, Severity and Frequency Based on Common Terminology Criteria for Adverse Events (CTCAE) V4.03
Grade 2
|
34 Participants
|
75 Participants
|
|
Adverse Events, Severity and Frequency Based on Common Terminology Criteria for Adverse Events (CTCAE) V4.03
Grade 3
|
59 Participants
|
103 Participants
|
|
Adverse Events, Severity and Frequency Based on Common Terminology Criteria for Adverse Events (CTCAE) V4.03
Grade 4
|
15 Participants
|
38 Participants
|
|
Adverse Events, Severity and Frequency Based on Common Terminology Criteria for Adverse Events (CTCAE) V4.03
Grade 5
|
14 Participants
|
25 Participants
|
|
Adverse Events, Severity and Frequency Based on Common Terminology Criteria for Adverse Events (CTCAE) V4.03
Missing
|
0 Participants
|
1 Participants
|
Adverse Events
TTFields + Standard of Care
Serious events: 77 serious events
Other events: 126 other events
Deaths: 104 deaths
Standard of Care
Serious events: 55 serious events
Other events: 119 other events
Deaths: 122 deaths
Serious adverse events
| Measure |
TTFields + Standard of Care
n=141 participants at risk
TTFields were to be delivered for at least 18 hours per day on a monthly average until disease progression in the thorax and/or the liver or intolerable toxicity. Standard of care treatment was administered until disease progression or intolerable toxicity: Immune checkpoint inhibitor (Nivolumab - 240 mg every 2 weeks or 480 mg every 4 weeks or as a weight-based dose, Pembrolizumab - 200 mg every 3 weeks or 400 mg every 6 weeks, or as a weight-based dose, Atezolizumab - 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks) OR docetaxel (75 mg/m2 IV over 1 hour every 3 weeks).
|
Standard of Care
n=141 participants at risk
Standard of care treatment was administered until disease progression or intolerable toxicity: Immune checkpoint inhibitor (Nivolumab - 240 mg every 2 weeks or 480 mg every 4 weeks or as a weight-based dose, or Pembrolizumab - 200 mg every 3 weeks or 400 mg every 6 weeks, or as a weight-based dose, or Atezolizumab - 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks) OR docetaxel (75 mg/m2 IV over 1 hour every 3 weeks).
|
|---|---|---|
|
Cardiac disorders
Cardiac disorders
|
4.3%
6/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
2.8%
4/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
|
Endocrine disorders
Endocrine disorders
|
0.71%
1/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
0.00%
0/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
7.1%
10/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
4.3%
6/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
|
General disorders
General disorders and administration site conditions
|
4.3%
6/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
5.0%
7/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
|
Hepatobiliary disorders
Hepatobiliary disorders
|
0.00%
0/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
1.4%
2/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
|
Infections and infestations
Infections and infestations
|
22.7%
32/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
16.3%
23/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
2.1%
3/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
0.00%
0/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
|
Investigations
Investigations
|
0.71%
1/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
0.71%
1/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders
|
3.5%
5/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
1.4%
2/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
0.00%
0/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
1.4%
2/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant, and unspecified (incl. cysts and polyps)
|
5.0%
7/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
2.1%
3/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
|
Nervous system disorders
Nervous system disorders
|
5.7%
8/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
3.5%
5/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
|
Renal and urinary disorders
Renal and urinary disorders
|
0.71%
1/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
0.71%
1/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic, and mediastinal disorders
|
18.4%
26/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
16.3%
23/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
1.4%
2/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
0.00%
0/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
|
Vascular disorders
Vascular disorders
|
0.71%
1/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
0.00%
0/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
Other adverse events
| Measure |
TTFields + Standard of Care
n=141 participants at risk
TTFields were to be delivered for at least 18 hours per day on a monthly average until disease progression in the thorax and/or the liver or intolerable toxicity. Standard of care treatment was administered until disease progression or intolerable toxicity: Immune checkpoint inhibitor (Nivolumab - 240 mg every 2 weeks or 480 mg every 4 weeks or as a weight-based dose, Pembrolizumab - 200 mg every 3 weeks or 400 mg every 6 weeks, or as a weight-based dose, Atezolizumab - 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks) OR docetaxel (75 mg/m2 IV over 1 hour every 3 weeks).
|
Standard of Care
n=141 participants at risk
Standard of care treatment was administered until disease progression or intolerable toxicity: Immune checkpoint inhibitor (Nivolumab - 240 mg every 2 weeks or 480 mg every 4 weeks or as a weight-based dose, or Pembrolizumab - 200 mg every 3 weeks or 400 mg every 6 weeks, or as a weight-based dose, or Atezolizumab - 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks) OR docetaxel (75 mg/m2 IV over 1 hour every 3 weeks).
|
|---|---|---|
|
General disorders
Fatigue
|
27.0%
38/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
38.3%
54/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
34.8%
49/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
27.7%
39/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
|
Blood and lymphatic system disorders
Anemia
|
22.0%
31/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
23.4%
33/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
18.4%
26/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
24.1%
34/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
40.4%
57/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
2.1%
3/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.7%
25/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
22.7%
32/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
|
Gastrointestinal disorders
Diarrhea
|
17.0%
24/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
18.4%
26/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
|
Gastrointestinal disorders
Nausea
|
19.1%
27/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
16.3%
23/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
|
Blood and lymphatic system disorders
Leukopenia
|
15.6%
22/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
17.0%
24/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
|
Metabolism and nutrition disorders
Anorexia
|
16.3%
23/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
15.6%
22/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
|
Infections and infestations
Pneumonia
|
5.0%
7/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
9.2%
13/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
|
General disorders
Localized edema
|
13.5%
19/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
17.0%
24/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
|
Infections and infestations
Respiratory tract infection
|
13.5%
19/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
16.3%
23/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
9.2%
13/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
18.4%
26/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
|
General disorders
Pain
|
12.8%
18/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
13.5%
19/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
|
Gastrointestinal disorders
Constipation
|
11.3%
16/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
12.8%
18/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.3%
23/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
6.4%
9/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
|
Gastrointestinal disorders
Vomiting
|
9.2%
13/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
11.3%
16/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
|
Investigations
Hepatic enzyme increased
|
9.2%
13/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
12.1%
17/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
7.8%
11/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
13.5%
19/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
11.3%
16/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
9.2%
13/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
8.5%
12/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
12.1%
17/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
|
Nervous system disorders
Headache
|
7.8%
11/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
9.9%
14/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
|
Nervous system disorders
Neuropathy peripheral
|
7.8%
11/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
10.6%
15/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
|
General disorders
Pyrexia
|
5.7%
8/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
12.1%
17/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorhage
|
5.0%
7/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
7.8%
11/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
|
Investigations
Weight decreased
|
7.1%
10/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
9.2%
13/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
|
Skin and subcutaneous tissue disorders
Rash
|
13.5%
19/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
2.1%
3/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
7.8%
11/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
7.1%
10/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
|
Investigations
Blood creatinine increased
|
7.1%
10/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
7.1%
10/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
5.7%
8/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
7.1%
10/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
10.6%
15/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
2.8%
4/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
|
Psychiatric disorders
Sleep disorder
|
5.7%
8/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
8.5%
12/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
|
Gastrointestinal disorders
Abdominal Pain
|
7.1%
10/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
6.4%
9/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
|
Infections and infestations
Infection
|
5.7%
8/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
5.0%
7/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
|
Nervous system disorders
Dizziness
|
5.0%
7/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
6.4%
9/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.7%
8/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
6.4%
9/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
|
Gastrointestinal disorders
Mouth ulceration
|
4.3%
6/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
7.8%
11/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
|
Infections and infestations
Urinary tract infection
|
5.0%
7/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
6.4%
9/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
|
Gastrointestinal disorders
Dysphagia
|
9.2%
13/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
1.4%
2/141 • From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).
All-Cause Mortality were reported from the intention-to-treat population. Serious and Other Adverse Events (AEs) were reported for the safety population, defined as subjects who received the interventional therapy. The descriptions and grading scales found in the revised Common Terminology Criteria for AEs (CTCAE) V5.0 are utilized for assessing severity of AEs in the study. A modified grading was used to describe TTFields-related skin reactions.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines. If patentable information is discovered, additional 60 days are required for review.
- Publication restrictions are in place
Restriction type: OTHER