Trial Outcomes & Findings for Effect of Tumor Treating Fields (TTFields, 150 kHz) as Front-Line Treatment of Locally-advanced Pancreatic Adenocarcinoma Concomitant With Gemcitabine and Nab-paclitaxel (PANOVA-3) (NCT NCT03377491)
NCT ID: NCT03377491
Last Updated: 2026-01-21
Results Overview
Overall survival of subjects treated with TTFields concomitant with gemcitabine and nab-paclitaxel in the first line treatment of unresectable, locally advanced pancreatic cancer subjects, compared to overall survival of subjects treated with chemotherapy alone, measured as the period between the time of randomization and the time of death.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
571 participants
Primary outcome timeframe
From randomization until death from any cause or last known alive.
Results posted on
2026-01-21
Participant Flow
Participant milestones
| Measure |
TTFields + Standard of Care
TTFields were to be delivered until local disease progression. Standard of care treatment was administered until disease progression or intolerable toxicity (Nab-paclitaxel 125 mg/m2 and Gemcitabine 1000 mg/m2 on Days 1, 8, 15 of each 28-day cycle).
|
Standard of Care
Standard of care treatment was administered until disease progression or intolerable toxicity (Nab-paclitaxel 125 mg/m2 and Gemcitabine 1000 mg/m2 on Days 1, 8, 15 of each 28-day cycle).
|
|---|---|---|
|
Overall Study
STARTED
|
285
|
286
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
285
|
286
|
Reasons for withdrawal
| Measure |
TTFields + Standard of Care
TTFields were to be delivered until local disease progression. Standard of care treatment was administered until disease progression or intolerable toxicity (Nab-paclitaxel 125 mg/m2 and Gemcitabine 1000 mg/m2 on Days 1, 8, 15 of each 28-day cycle).
|
Standard of Care
Standard of care treatment was administered until disease progression or intolerable toxicity (Nab-paclitaxel 125 mg/m2 and Gemcitabine 1000 mg/m2 on Days 1, 8, 15 of each 28-day cycle).
|
|---|---|---|
|
Overall Study
Death
|
193
|
211
|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
|
Overall Study
Withdrawal by Subject
|
42
|
26
|
|
Overall Study
Study closure
|
40
|
37
|
|
Overall Study
Other
|
8
|
9
|
Baseline Characteristics
Measure Description: Participants level of functional ability and the extent of disease affect of their daily life were assessed. A score of 0 indicates a better health condition, and a score of 2 indicates a worse health condition.
Baseline characteristics by cohort
| Measure |
TTFields + Standard of Care
n=310 Lesions
TTFields were to be delivered until local disease progression. Standard of care treatment was administered until disease progression or intolerable toxicity (Nab-paclitaxel 125 mg/m2 and Gemcitabine 1000 mg/m2 on Days 1, 8, 15 of each 28-day cycle).
|
Standard of Care
n=309 Lesions
Standard of care treatment was administered until disease progression or intolerable toxicity (Nab-paclitaxel 125 mg/m2 and Gemcitabine 1000 mg/m2 on Days 1, 8, 15 of each 28-day cycle).
|
Total
n=619 Lesions
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67 Years
n=37 Participants
|
67.5 Years
n=44 Participants
|
67 Years
n=40 Participants
|
|
Sex: Female, Male
Female
|
138 Participants
n=37 Participants
|
161 Participants
n=44 Participants
|
299 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
147 Participants
n=37 Participants
|
125 Participants
n=44 Participants
|
272 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
9 Participants
n=37 Participants
|
4 Participants
n=44 Participants
|
13 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Asian
|
44 Participants
n=37 Participants
|
44 Participants
n=44 Participants
|
88 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
16 Participants
n=37 Participants
|
14 Participants
n=44 Participants
|
30 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
White
|
202 Participants
n=37 Participants
|
204 Participants
n=44 Participants
|
406 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=37 Participants
|
5 Participants
n=44 Participants
|
8 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
11 Participants
n=37 Participants
|
15 Participants
n=44 Participants
|
26 Participants
n=40 Participants
|
|
Region of Enrollment
North America
|
123 Participants
n=37 Participants
|
125 Participants
n=44 Participants
|
248 Participants
n=40 Participants
|
|
Region of Enrollment
Eastern Europe
|
43 Participants
n=37 Participants
|
42 Participants
n=44 Participants
|
85 Participants
n=40 Participants
|
|
Region of Enrollment
Western Europe and Israel
|
62 Participants
n=37 Participants
|
61 Participants
n=44 Participants
|
123 Participants
n=40 Participants
|
|
Region of Enrollment
Rest of World
|
57 Participants
n=37 Participants
|
58 Participants
n=44 Participants
|
115 Participants
n=40 Participants
|
|
ECOG Performance Status
0
|
109 Participants
n=37 Participants • Measure Description: Participants level of functional ability and the extent of disease affect of their daily life were assessed. A score of 0 indicates a better health condition, and a score of 2 indicates a worse health condition.
|
111 Participants
n=44 Participants • Measure Description: Participants level of functional ability and the extent of disease affect of their daily life were assessed. A score of 0 indicates a better health condition, and a score of 2 indicates a worse health condition.
|
220 Participants
n=40 Participants • Measure Description: Participants level of functional ability and the extent of disease affect of their daily life were assessed. A score of 0 indicates a better health condition, and a score of 2 indicates a worse health condition.
|
|
ECOG Performance Status
1
|
166 Participants
n=37 Participants • Measure Description: Participants level of functional ability and the extent of disease affect of their daily life were assessed. A score of 0 indicates a better health condition, and a score of 2 indicates a worse health condition.
|
163 Participants
n=44 Participants • Measure Description: Participants level of functional ability and the extent of disease affect of their daily life were assessed. A score of 0 indicates a better health condition, and a score of 2 indicates a worse health condition.
|
329 Participants
n=40 Participants • Measure Description: Participants level of functional ability and the extent of disease affect of their daily life were assessed. A score of 0 indicates a better health condition, and a score of 2 indicates a worse health condition.
|
|
ECOG Performance Status
2
|
10 Participants
n=37 Participants • Measure Description: Participants level of functional ability and the extent of disease affect of their daily life were assessed. A score of 0 indicates a better health condition, and a score of 2 indicates a worse health condition.
|
12 Participants
n=44 Participants • Measure Description: Participants level of functional ability and the extent of disease affect of their daily life were assessed. A score of 0 indicates a better health condition, and a score of 2 indicates a worse health condition.
|
22 Participants
n=40 Participants • Measure Description: Participants level of functional ability and the extent of disease affect of their daily life were assessed. A score of 0 indicates a better health condition, and a score of 2 indicates a worse health condition.
|
|
BMI Group
< 25 kg/m2
|
166 Participants
n=37 Participants
|
174 Participants
n=44 Participants
|
340 Participants
n=40 Participants
|
|
BMI Group
≥ 25 kg/m2
|
117 Participants
n=37 Participants
|
108 Participants
n=44 Participants
|
225 Participants
n=40 Participants
|
|
BMI Group
Missing BMI
|
2 Participants
n=37 Participants
|
4 Participants
n=44 Participants
|
6 Participants
n=40 Participants
|
|
CA19.9
Low (≤37 U/mL)
|
48 Participants
n=37 Participants
|
44 Participants
n=44 Participants
|
92 Participants
n=40 Participants
|
|
CA19.9
Moderate (38-1,000 U/mL)
|
140 Participants
n=37 Participants
|
152 Participants
n=44 Participants
|
292 Participants
n=40 Participants
|
|
CA19.9
High (>1,000 U/mL)
|
88 Participants
n=37 Participants
|
79 Participants
n=44 Participants
|
167 Participants
n=40 Participants
|
|
CA19.9
Untested
|
9 Participants
n=37 Participants
|
11 Participants
n=44 Participants
|
20 Participants
n=40 Participants
|
|
Target Lesion Site
Head of Pancreas
|
164 Lesions
n=310 Lesions
|
160 Lesions
n=309 Lesions
|
324 Lesions
n=619 Lesions
|
|
Target Lesion Site
Body of Pancreas
|
82 Lesions
n=310 Lesions
|
81 Lesions
n=309 Lesions
|
163 Lesions
n=619 Lesions
|
|
Target Lesion Site
Tail of Pancreas
|
9 Lesions
n=310 Lesions
|
19 Lesions
n=309 Lesions
|
28 Lesions
n=619 Lesions
|
|
Target Lesion Site
Other: Multiple regions in pancreas
|
26 Lesions
n=310 Lesions
|
22 Lesions
n=309 Lesions
|
48 Lesions
n=619 Lesions
|
|
Target Lesion Site
Other: Extra-pancreatic
|
29 Lesions
n=310 Lesions
|
27 Lesions
n=309 Lesions
|
56 Lesions
n=619 Lesions
|
PRIMARY outcome
Timeframe: From randomization until death from any cause or last known alive.Overall survival of subjects treated with TTFields concomitant with gemcitabine and nab-paclitaxel in the first line treatment of unresectable, locally advanced pancreatic cancer subjects, compared to overall survival of subjects treated with chemotherapy alone, measured as the period between the time of randomization and the time of death.
Outcome measures
| Measure |
TTFields + Standard of Care
n=285 Participants
TTFields were to be delivered until local disease progression. Standard of care treatment was administered until disease progression or intolerable toxicity (Nab-paclitaxel 125 mg/m2 and Gemcitabine 1000 mg/m2 on Days 1, 8, 15 of each 28-day cycle).
|
Standard of Care
n=286 Participants
Standard of care treatment was administered until disease progression or intolerable toxicity (Nab-paclitaxel 125 mg/m2 and Gemcitabine 1000 mg/m2 on Days 1, 8, 15 of each 28-day cycle).
|
|---|---|---|
|
Overall Survival of Subjects Treated With TTFields Concomitant With Gemcitabine and Nab-paclitaxel vs Chemotherapy Alone
|
16.20 Months
Interval 15.01 to 17.97
|
14.16 Months
Interval 12.81 to 15.44
|
SECONDARY outcome
Timeframe: From randomization until radiologic disease progression per RECIST v1.1 or death, whichever occurs first.Progression-free survival of subjects treated with TTFields concomitant with gemcitabine and nab-paclitaxel in the first line treatment of unresectable, locally advanced pancreatic cancer subjects, compared to the progression-free survival of subjects treated with chemotherapy alone, measured from the time of randomization and based on CT scans collected on the study, using the revised RECIST V1.1 Criteria. Progression is defined using the RECIST 1.1 criteria: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, in addition the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, progression was defined as unequivocal progression (an overall level of substantial worsening in non-target disease) of existing non-target lesions. The appearance of one or more new lesions is also considered progression.
Outcome measures
| Measure |
TTFields + Standard of Care
n=285 Participants
TTFields were to be delivered until local disease progression. Standard of care treatment was administered until disease progression or intolerable toxicity (Nab-paclitaxel 125 mg/m2 and Gemcitabine 1000 mg/m2 on Days 1, 8, 15 of each 28-day cycle).
|
Standard of Care
n=286 Participants
Standard of care treatment was administered until disease progression or intolerable toxicity (Nab-paclitaxel 125 mg/m2 and Gemcitabine 1000 mg/m2 on Days 1, 8, 15 of each 28-day cycle).
|
|---|---|---|
|
Progression-free Survival of Subjects Treated With TTFields Concomitant With Gemcitabine and Nab-paclitaxel vs Chemotherapy Alone
|
10.61 Months
Interval 9.2 to 12.19
|
9.33 Months
Interval 7.59 to 11.07
|
SECONDARY outcome
Timeframe: From randomization until local disease progression per RECIST v1.1 (in the absence of distant metastasis) or death, whichever occurs first.Local progression-free survival of subjects treated with TTFields concomitant with gemcitabine and nab-paclitaxel in the first line treatment of unresectable, locally advanced pancreatic cancer subjects, compared to the local progression-free survival of subjects treated with chemotherapy alone, measured from the time of randomization and based on CT scans collected on the study, using the revised RECIST V1.1 Criteria. Local progression is defined per RECIST 1.1 in the absence of distant metastasis: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, in addition the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, progression was defined as unequivocal progression (an overall level of substantial worsening) of existing non-target lesions. The appearance of one or more new lesions is also considered progression.
Outcome measures
| Measure |
TTFields + Standard of Care
n=285 Participants
TTFields were to be delivered until local disease progression. Standard of care treatment was administered until disease progression or intolerable toxicity (Nab-paclitaxel 125 mg/m2 and Gemcitabine 1000 mg/m2 on Days 1, 8, 15 of each 28-day cycle).
|
Standard of Care
n=286 Participants
Standard of care treatment was administered until disease progression or intolerable toxicity (Nab-paclitaxel 125 mg/m2 and Gemcitabine 1000 mg/m2 on Days 1, 8, 15 of each 28-day cycle).
|
|---|---|---|
|
Local Progression-free Survival of Subjects Treated With TTFields Concomitant With Gemcitabine and Nab-paclitaxel vs Chemotherapy Alone
|
12.45 Months
Interval 10.68 to 14.52
|
10.41 Months
Interval 9.13 to 11.79
|
SECONDARY outcome
Timeframe: From randomization until radiologic disease progression per RECIST v1.1 or end of tumor assessment follow-up.Population: Per SAP, subjects without evaluable post-baseline tumor assessments (unevaluable/missing follow-up data) were excluded. Only subjects with ORR information per RECIST v1.1 were included, which explains why the analyzed N (244 and 243) is different than the ITT population (285 vs 286).
Objective Response Rate (ORR) was assessed per RECIST v1.1. Complete Response (CR): disappearance of all target and non-target lesions and reduction of pathological lymph nodes to \<10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions from baseline without new lesions or progression of non-target lesions. ORR is defined as the percentage of participants whose best overall response was CR or PR.
Outcome measures
| Measure |
TTFields + Standard of Care
n=244 Participants
TTFields were to be delivered until local disease progression. Standard of care treatment was administered until disease progression or intolerable toxicity (Nab-paclitaxel 125 mg/m2 and Gemcitabine 1000 mg/m2 on Days 1, 8, 15 of each 28-day cycle).
|
Standard of Care
n=243 Participants
Standard of care treatment was administered until disease progression or intolerable toxicity (Nab-paclitaxel 125 mg/m2 and Gemcitabine 1000 mg/m2 on Days 1, 8, 15 of each 28-day cycle).
|
|---|---|---|
|
Objective Response Rate of Subjects Treated With TTFields Concomitant With Gemcitabine and Nab-paclitaxel vs Chemotherapy Alone
|
88 Participants
|
73 Participants
|
SECONDARY outcome
Timeframe: From randomization through 12 months after randomization.Population: The 1-year OS rate is a Kaplan-Meier (KM) estimate of survival at 12 months in the ITT population. As a time-to-event estimate incorporating censoring, the percentage may not correspond exactly to a simple whole-number count of participants. KM estimate represents risk-adjusted survival probability.
One-year survival rate of subjects treated with TTFields concomitant with gemcitabine and nab-paclitaxel in the first line treatment of unresectable, locally advanced pancreatic cancer subjects, compared to the 1-year survival rate of subjects treated with chemotherapy alone.
Outcome measures
| Measure |
TTFields + Standard of Care
n=285 Participants
TTFields were to be delivered until local disease progression. Standard of care treatment was administered until disease progression or intolerable toxicity (Nab-paclitaxel 125 mg/m2 and Gemcitabine 1000 mg/m2 on Days 1, 8, 15 of each 28-day cycle).
|
Standard of Care
n=286 Participants
Standard of care treatment was administered until disease progression or intolerable toxicity (Nab-paclitaxel 125 mg/m2 and Gemcitabine 1000 mg/m2 on Days 1, 8, 15 of each 28-day cycle).
|
|---|---|---|
|
One-year Survival Rate of Subjects Treated With TTFields Concomitant With Gemcitabine and Nab-paclitaxel vs Chemotherapy Alone
|
68.1 percentage of subjects alive at 1 year
Interval 62.0 to 73.5
|
60.2 percentage of subjects alive at 1 year
Interval 54.2 to 65.7
|
SECONDARY outcome
Timeframe: From randomization until the first ≥10-point deterioration without subsequent improvement, or death, assessed for the duration of study follow-up.Quality of life deterioration-free survival (DFS) was assessed using the EORTC QLQ-C30 and pancreatic cancer-specific QLQ-PAN26 questionnaires. Higher scores on functional and global health status scales indicate better functioning, whereas higher symptom scores indicate worse symptoms. DFS was defined as the time from randomization to the first ≥10-point deterioration from baseline without a subsequent ≥10-point improvement, or death. DFS was evaluated separately for each QoL domain included in the analysis.
Outcome measures
| Measure |
TTFields + Standard of Care
n=285 Participants
TTFields were to be delivered until local disease progression. Standard of care treatment was administered until disease progression or intolerable toxicity (Nab-paclitaxel 125 mg/m2 and Gemcitabine 1000 mg/m2 on Days 1, 8, 15 of each 28-day cycle).
|
Standard of Care
n=286 Participants
Standard of care treatment was administered until disease progression or intolerable toxicity (Nab-paclitaxel 125 mg/m2 and Gemcitabine 1000 mg/m2 on Days 1, 8, 15 of each 28-day cycle).
|
|---|---|---|
|
Quality of Life of Subjects Treated With TTFields Concomitant With Gemcitabine and Nab-paclitaxel vs Chemotherapy Alone
Global health status / Quality of Life
|
7.1 Months
Interval 5.7 to 9.4
|
5.7 Months
Interval 4.1 to 7.4
|
|
Quality of Life of Subjects Treated With TTFields Concomitant With Gemcitabine and Nab-paclitaxel vs Chemotherapy Alone
Pain (EORTC QLQ-C30)
|
10.1 Months
Interval 8.0 to 11.6
|
7.4 Months
Interval 5.9 to 9.0
|
|
Quality of Life of Subjects Treated With TTFields Concomitant With Gemcitabine and Nab-paclitaxel vs Chemotherapy Alone
Pancreatic pain (EORTC QLQ-PAN26)
|
14.7 Months
Interval 12.0 to 16.5
|
10.2 Months
Interval 8.8 to 12.2
|
|
Quality of Life of Subjects Treated With TTFields Concomitant With Gemcitabine and Nab-paclitaxel vs Chemotherapy Alone
Digestive problems (EORTC QLQ-PAN26)
|
8.3 Months
Interval 6.1 to 11.2
|
5.7 Months
Interval 4.4 to 7.4
|
SECONDARY outcome
Timeframe: From randomization until a ≥20-point increase from baseline in pain on the patient-reported visual analogue scale (0-100) or death, whichever occurs first.Pain-free survival was measured as the duration between the time of randomization until a greater than or equal to twenty-point increase from baseline in a patient self-reported visual analogue scale (VAS) was recorded or death, whichever occurred first.
Outcome measures
| Measure |
TTFields + Standard of Care
n=285 Participants
TTFields were to be delivered until local disease progression. Standard of care treatment was administered until disease progression or intolerable toxicity (Nab-paclitaxel 125 mg/m2 and Gemcitabine 1000 mg/m2 on Days 1, 8, 15 of each 28-day cycle).
|
Standard of Care
n=286 Participants
Standard of care treatment was administered until disease progression or intolerable toxicity (Nab-paclitaxel 125 mg/m2 and Gemcitabine 1000 mg/m2 on Days 1, 8, 15 of each 28-day cycle).
|
|---|---|---|
|
Pain-free Survival of Subjects Treated With TTFields Concomitant With Gemcitabine and Nab-paclitaxel vs Chemotherapy Alone
|
15.18 Months
Interval 10.28 to 22.77
|
9.13 Months
Interval 7.43 to 12.68
|
SECONDARY outcome
Timeframe: From randomization until the first paracentesis or death, whichever occurs first.Puncture-free survival of subjects treated with TTFields concomitant with gemcitabine and nab-paclitaxel in the first line treatment of unresectable, locally advanced pancreatic cancer subjects, compared to puncture-free survival of subjects treated with chemotherapy alone, measured as the duration between randomization until the first need for paracentesis or death, whichever occurs first.
Outcome measures
| Measure |
TTFields + Standard of Care
n=285 Participants
TTFields were to be delivered until local disease progression. Standard of care treatment was administered until disease progression or intolerable toxicity (Nab-paclitaxel 125 mg/m2 and Gemcitabine 1000 mg/m2 on Days 1, 8, 15 of each 28-day cycle).
|
Standard of Care
n=286 Participants
Standard of care treatment was administered until disease progression or intolerable toxicity (Nab-paclitaxel 125 mg/m2 and Gemcitabine 1000 mg/m2 on Days 1, 8, 15 of each 28-day cycle).
|
|---|---|---|
|
Puncture-free Survival of Subjects Treated With TTFields Concomitant With Gemcitabine and Nab-paclitaxel vs Chemotherapy Alone
|
22.8 months
Interval 15.5 to
NA indicates that the upper limit of the 95% confidence interval could not be estimated due to an insufficient number of events beyond the median.
|
16.6 months
Interval 13.1 to
NA indicates that the upper limit of the 95% confidence interval could not be estimated due to an insufficient number of events beyond the median.
|
SECONDARY outcome
Timeframe: From randomization through the end of study follow-up. Surgical resections were captured throughout study follow-up, up to approximately 18 months.Resectability rate defined as the number and percentage of patients whose tumors were deemed resectable and who underwent surgery.
Outcome measures
| Measure |
TTFields + Standard of Care
n=285 Participants
TTFields were to be delivered until local disease progression. Standard of care treatment was administered until disease progression or intolerable toxicity (Nab-paclitaxel 125 mg/m2 and Gemcitabine 1000 mg/m2 on Days 1, 8, 15 of each 28-day cycle).
|
Standard of Care
n=286 Participants
Standard of care treatment was administered until disease progression or intolerable toxicity (Nab-paclitaxel 125 mg/m2 and Gemcitabine 1000 mg/m2 on Days 1, 8, 15 of each 28-day cycle).
|
|---|---|---|
|
Resectability Rate of Subjects Treated With TTFields Concomitant With Gemcitabine and Nab-paclitaxel vs Chemotherapy Alone
|
20 Participants
Interval 4.3 to 10.6
|
29 Participants
Interval 6.9 to 14.2
|
Adverse Events
TTFields + Standard of Care
Serious events: 147 serious events
Other events: 267 other events
Deaths: 199 deaths
Standard of Care
Serious events: 131 serious events
Other events: 268 other events
Deaths: 223 deaths
Serious adverse events
| Measure |
TTFields + Standard of Care
n=274 participants at risk
TTFields were to be delivered for at least 18 hours per day on a monthly average until local disease progression. Standard of care treatment was administered until disease progression or intolerable toxicity (Nab-paclitaxel 125 mg/m2 and Gemcitabine 1000 mg/m2 on Days 1, 8, 15 of each 28-day cycle).
|
Standard of Care
n=273 participants at risk
Standard of care treatment was administered until disease progression or intolerable toxicity (Nab-paclitaxel 125 mg/m2 and Gemcitabine 1000 mg/m2 on Days 1, 8, 15 of each 28-day cycle).
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.1%
3/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
4.4%
12/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.6%
7/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
1.5%
4/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Cardiac disorders
Arrhythmia
|
1.5%
4/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
1.1%
3/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
1.5%
4/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
2.2%
6/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.8%
5/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.73%
2/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Blood and lymphatic system disorders
Jaundice
|
1.5%
4/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.73%
2/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.73%
2/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.73%
2/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
1.1%
3/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Blood and lymphatic system disorders
Haemolytic uraemic syndrome
|
0.00%
0/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.37%
1/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.37%
1/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.36%
1/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.00%
0/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Cardiac disorders
Cardiac failure
|
2.2%
6/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.37%
1/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Cardiac disorders
Myocardial infarction
|
0.36%
1/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
1.1%
3/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Cardiac disorders
Pericardial effusion
|
0.36%
1/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.37%
1/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Cardiac disorders
Cardiac tamponade
|
0.36%
1/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.00%
0/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.37%
1/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.36%
1/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.00%
0/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.36%
1/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.00%
0/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.37%
1/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Gastrointestinal disorders
Vomiting
|
1.5%
4/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
2.6%
7/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Gastrointestinal disorders
Colitis
|
2.6%
7/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
1.1%
3/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.73%
2/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
2.6%
7/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Gastrointestinal disorders
Abdominal Pain
|
2.2%
6/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.73%
2/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Gastrointestinal disorders
Duodenal obstruction
|
2.2%
6/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.73%
2/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
1.5%
4/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
1.1%
3/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.73%
2/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
1.5%
4/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Gastrointestinal disorders
Ascites
|
1.5%
4/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.37%
1/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
1.5%
4/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.73%
2/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.73%
2/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Gastrointestinal disorders
Duodenal stenosis
|
0.36%
1/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.73%
2/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.73%
2/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.37%
1/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Gastrointestinal disorders
Constipation
|
0.73%
2/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.00%
0/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.73%
2/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.73%
2/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.00%
0/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.00%
0/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.37%
1/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.36%
1/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.00%
0/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Gastrointestinal disorders
Gastritis
|
0.36%
1/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.00%
0/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Gastrointestinal disorders
Gastrointestinal toxicity
|
0.00%
0/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.37%
1/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.37%
1/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Gastrointestinal disorders
Haematemesis
|
0.36%
1/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.00%
0/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Gastrointestinal disorders
Haemoperitoneum
|
0.36%
1/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.00%
0/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.36%
1/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.00%
0/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Gastrointestinal disorders
Intra-abdominal fluid collection
|
0.00%
0/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.37%
1/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.37%
1/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Gastrointestinal disorders
Nausea
|
0.36%
1/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.00%
0/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Gastrointestinal disorders
Pancreatic failure
|
0.36%
1/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.00%
0/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.37%
1/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.00%
0/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.37%
1/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
General disorders
Pyrexia
|
2.9%
8/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
1.8%
5/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
General disorders
Fatigue
|
1.5%
4/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
1.1%
3/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
General disorders
General physical health deterioration
|
0.36%
1/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
1.5%
4/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
General disorders
Generalized edema
|
0.73%
2/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.00%
0/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
General disorders
Hypothermia
|
0.36%
1/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.00%
0/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
General disorders
Edema
|
0.36%
1/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.00%
0/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
General disorders
Peripheral edema
|
0.36%
1/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.00%
0/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
General disorders
Pain
|
0.36%
1/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.00%
0/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Hepatobiliary disorders
Cholangitis
|
5.8%
16/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
3.7%
10/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
5.5%
15/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
3.3%
9/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Hepatobiliary disorders
Cholecystitis
|
1.8%
5/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
1.8%
5/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.73%
2/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.73%
2/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Hepatobiliary disorders
Gallbladder rupture
|
0.36%
1/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.37%
1/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.36%
1/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.37%
1/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.73%
2/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.00%
0/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Hepatobiliary disorders
Cholestasis
|
0.36%
1/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.00%
0/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Hepatobiliary disorders
Hepatobiliary disease
|
0.00%
0/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.37%
1/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Hepatobiliary disorders
Perforation bile duct
|
0.36%
1/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.00%
0/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.37%
1/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Infections and infestations
Sepsis
|
6.9%
19/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
9.5%
26/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Infections and infestations
Pneumonia
|
5.1%
14/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
3.3%
9/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Infections and infestations
Infection
|
2.9%
8/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
2.6%
7/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Infections and infestations
COVID-19
|
1.8%
5/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
1.5%
4/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Infections and infestations
Urinary tract infection
|
1.1%
3/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
2.2%
6/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Infections and infestations
Skin infection
|
1.1%
3/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
1.5%
4/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Infections and infestations
Bacteraemia
|
1.5%
4/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.73%
2/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Infections and infestations
Abscess
|
0.36%
1/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
1.5%
4/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Infections and infestations
Biliary tract infection
|
1.5%
4/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.37%
1/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Infections and infestations
Respiratory tract infection
|
0.36%
1/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.73%
2/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.73%
2/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Infections and infestations
Peritonitis
|
0.73%
2/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.00%
0/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Infections and infestations
Catheter site infection
|
0.36%
1/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.00%
0/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Infections and infestations
Cystitis
|
0.36%
1/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.00%
0/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Infections and infestations
Fournier's gangrene
|
0.00%
0/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.37%
1/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Infections and infestations
Gastroenteritis
|
0.36%
1/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.00%
0/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Infections and infestations
Hepatobiliary infection
|
0.00%
0/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.37%
1/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.36%
1/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.00%
0/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.37%
1/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.73%
2/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.73%
2/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.36%
1/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.37%
1/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.36%
1/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.00%
0/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.36%
1/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.00%
0/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
2.6%
7/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.36%
1/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.73%
2/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.73%
2/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.00%
0/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.73%
2/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.00%
0/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Metabolism and nutrition disorders
Hyperglycaemic hyperosmolar nonketotic syndrome
|
0.36%
1/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.37%
1/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.37%
1/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.36%
1/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.00%
0/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.36%
1/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.00%
0/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Metabolism and nutrition disorders
Pancreatogenous diabetes
|
0.36%
1/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.00%
0/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Metabolism and nutrition disorders
Starvation ketoacidosis
|
0.00%
0/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.37%
1/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.36%
1/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.73%
2/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.37%
1/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.36%
1/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.00%
0/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.37%
1/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Nervous system disorders
Syncope
|
0.73%
2/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.37%
1/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Nervous system disorders
Seizure
|
0.73%
2/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.00%
0/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Nervous system disorders
Cerebral infarction
|
0.36%
1/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.00%
0/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Nervous system disorders
Intracranial pressure increased
|
0.36%
1/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.00%
0/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Nervous system disorders
Ischaemic stroke
|
0.36%
1/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.00%
0/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.37%
1/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Product Issues
Device occlusion
|
2.6%
7/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.37%
1/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Product Issues
Stent malfunction
|
0.36%
1/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.37%
1/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Psychiatric disorders
Confusional state
|
0.36%
1/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.73%
2/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.37%
1/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Psychiatric disorders
Eating disorder
|
0.36%
1/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.00%
0/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.5%
4/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
2.2%
6/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Renal and urinary disorders
Renal failure
|
0.36%
1/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
1.5%
4/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Renal and urinary disorders
Nephritic syndrome
|
0.00%
0/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.37%
1/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.8%
5/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
1.5%
4/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.73%
2/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
1.1%
3/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.1%
3/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.37%
1/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.5%
4/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.00%
0/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.73%
2/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.37%
1/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.36%
1/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.37%
1/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.36%
1/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.00%
0/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pneumonia syndrome
|
0.36%
1/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.00%
0/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.36%
1/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.00%
0/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
0.00%
0/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.37%
1/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.36%
1/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.00%
0/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.36%
1/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.00%
0/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary infarction
|
0.36%
1/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.00%
0/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Vascular disorders
Deep vein thrombosis
|
0.73%
2/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
1.1%
3/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Vascular disorders
Hypertension
|
0.36%
1/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.37%
1/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Vascular disorders
Embolism
|
0.36%
1/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.00%
0/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Vascular disorders
Haematoma
|
0.00%
0/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.37%
1/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Vascular disorders
Haemorrhage
|
0.36%
1/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.00%
0/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Vascular disorders
Hypotension
|
0.36%
1/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.00%
0/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Vascular disorders
Hypovolaemic shock
|
0.36%
1/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.00%
0/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Vascular disorders
Peripheral venous disease
|
0.36%
1/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.00%
0/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Vascular disorders
Shock haemorrhagic
|
0.36%
1/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.00%
0/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.00%
0/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.37%
1/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
0.37%
1/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
Other adverse events
| Measure |
TTFields + Standard of Care
n=274 participants at risk
TTFields were to be delivered for at least 18 hours per day on a monthly average until local disease progression. Standard of care treatment was administered until disease progression or intolerable toxicity (Nab-paclitaxel 125 mg/m2 and Gemcitabine 1000 mg/m2 on Days 1, 8, 15 of each 28-day cycle).
|
Standard of Care
n=273 participants at risk
Standard of care treatment was administered until disease progression or intolerable toxicity (Nab-paclitaxel 125 mg/m2 and Gemcitabine 1000 mg/m2 on Days 1, 8, 15 of each 28-day cycle).
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
62.4%
171/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
65.9%
180/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Cardiac disorders
Arrhythmia
|
5.1%
14/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
5.1%
14/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Blood and lymphatic system disorders
Anemia
|
58.8%
161/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
56.8%
155/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
44.5%
122/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
48.4%
132/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Blood and lymphatic system disorders
Leukopenia
|
31.0%
85/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
35.9%
98/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
8.0%
22/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
9.9%
27/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Gastrointestinal disorders
Diarrhea
|
43.4%
119/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
45.1%
123/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Gastrointestinal disorders
Nausea
|
39.1%
107/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
44.3%
121/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Gastrointestinal disorders
Vomiting
|
29.2%
80/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
28.2%
77/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Gastrointestinal disorders
Abdominal Pain
|
25.2%
69/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
29.7%
81/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Gastrointestinal disorders
Constipation
|
23.0%
63/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
20.9%
57/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Gastrointestinal disorders
Abdominal distension
|
9.1%
25/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
10.3%
28/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Gastrointestinal disorders
Mouth ulceration
|
8.0%
22/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
10.3%
28/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.3%
20/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
8.4%
23/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Gastrointestinal disorders
Ascites
|
7.7%
21/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
7.0%
19/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Gastrointestinal disorders
Dry mouth
|
6.6%
18/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
5.1%
14/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
General disorders
Fatigue
|
59.9%
164/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
54.2%
148/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
General disorders
Peripheral edema
|
39.1%
107/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
36.3%
99/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
General disorders
Pyrexia
|
26.6%
73/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
22.0%
60/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
General disorders
Pain
|
14.2%
39/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
9.9%
27/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Hepatobiliary disorders
Hyperbilirubinemia
|
8.8%
24/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
5.1%
14/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Infections and infestations
COVID-19
|
13.9%
38/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
11.7%
32/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Infections and infestations
Respiratory tract infection
|
11.7%
32/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
9.9%
27/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Infections and infestations
Urinary tract infection
|
10.6%
29/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
8.1%
22/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Infections and infestations
Infection
|
12.0%
33/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
8.1%
22/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Infections and infestations
Pneumonia
|
6.9%
19/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
4.4%
12/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Infections and infestations
Skin infection
|
5.8%
16/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
4.8%
13/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Injury, poisoning and procedural complications
Fall
|
6.9%
19/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
5.5%
15/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Investigations
Hepatic enzyme increased
|
27.4%
75/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
26.4%
72/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Investigations
Blood lactate dehydrogenase increased
|
4.7%
13/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
6.2%
17/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Investigations
Blood creatinine increased
|
4.0%
11/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
6.6%
18/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Metabolism and nutrition disorders
Anorexia
|
33.9%
93/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
37.0%
101/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
23.0%
63/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
25.6%
70/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
15.7%
43/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
9.5%
26/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
9.9%
27/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
10.6%
29/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
9.9%
27/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
8.4%
23/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Metabolism and nutrition disorders
Dehydration
|
7.7%
21/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
7.3%
20/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
5.8%
16/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
9.2%
25/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
6.9%
19/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
5.5%
15/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Metabolism and nutrition disorders
Hypoproteinemia
|
6.2%
17/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
5.5%
15/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
25.5%
70/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
28.9%
79/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
7.7%
21/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
5.5%
15/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Nervous system disorders
Neuropathy peripheral
|
40.9%
112/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
29.7%
81/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Nervous system disorders
Taste disorder
|
13.9%
38/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
12.8%
35/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Nervous system disorders
Dizziness
|
13.5%
37/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
10.3%
28/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Nervous system disorders
Headache
|
7.3%
20/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
7.0%
19/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Nervous system disorders
Hypoaesthesia
|
7.7%
21/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
4.4%
12/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Nervous system disorders
Paraesthesia
|
5.8%
16/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
4.4%
12/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Psychiatric disorders
Sleep disorder
|
13.9%
38/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
9.5%
26/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Psychiatric disorders
Depression
|
8.8%
24/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
3.7%
10/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Psychiatric disorders
Anxiety
|
5.1%
14/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
7.0%
19/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Renal and urinary disorders
Micturition disorder
|
5.5%
15/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
7.7%
21/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
14.2%
39/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
7.7%
21/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.5%
26/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
11.7%
32/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.7%
21/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
8.4%
23/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
25.9%
71/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
31.5%
86/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.9%
71/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
8.4%
23/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
29.9%
82/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
2.9%
8/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
22.3%
61/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
8.4%
23/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
17.9%
49/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
9.9%
27/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
13.1%
36/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
3.3%
9/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
5.5%
15/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
5.9%
16/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
7.3%
20/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
3.3%
9/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Vascular disorders
Hypertension
|
6.9%
19/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
9.9%
27/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
|
Vascular disorders
Hypotension
|
10.2%
28/274 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
6.6%
18/273 • Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years
AEs were reported for the safety population, defined as subjects who received any amount of study intervention. The descriptions and grading scales found in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 are utilized for assessing severity of adverse events in the study. However, the CTCAE does not include a scale that properly describes the skin toxicity associated with the NovoTTF-200T system and a modified grading for TTFields-related skin adverse events was used.
|
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