Trial Outcomes & Findings for Intravenous Palonosetron With Radiotherapy and Concomitant Temozolomide (NCT NCT00900757)
NCT ID: NCT00900757
Last Updated: 2019-08-28
Results Overview
The number of participants with unacceptable toxicity defined as ≥grade 3, non-hematologic toxicities that are possibly, probably or definitely related to the study regimen.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
57 participants
Primary outcome timeframe
6 weeks
Results posted on
2019-08-28
Participant Flow
Participant milestones
| Measure |
Palonosetron
Single Arm trial of Palonosetron for the prevention of RINV in primary malignant glioma patients receiving radiation therapy (RT) and concomitant temozolomide (TMZ)
Palonosetron (PALO): Eligible patients should receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of daily temozolomide for a total of six weeks of treatment. For each week of radiation patients will receive a single 0.25 mg intravenous dose of palonosetron 30 minutes before each week of radiation fraction. This schedule will be repeated for each week of radiation for a total of 6 weeks.
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|---|---|
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Overall Study
STARTED
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57
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Overall Study
COMPLETED
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38
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Overall Study
NOT COMPLETED
|
19
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Reasons for withdrawal
| Measure |
Palonosetron
Single Arm trial of Palonosetron for the prevention of RINV in primary malignant glioma patients receiving radiation therapy (RT) and concomitant temozolomide (TMZ)
Palonosetron (PALO): Eligible patients should receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of daily temozolomide for a total of six weeks of treatment. For each week of radiation patients will receive a single 0.25 mg intravenous dose of palonosetron 30 minutes before each week of radiation fraction. This schedule will be repeated for each week of radiation for a total of 6 weeks.
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|---|---|
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Overall Study
screen failure
|
19
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Baseline Characteristics
Intravenous Palonosetron With Radiotherapy and Concomitant Temozolomide
Baseline characteristics by cohort
| Measure |
Palonosetron
n=38 Participants
Single Arm trial of Palonosetron for the prevention of RINV in primary malignant glioma patients receiving radiation therapy (RT) and concomitant temozolomide (TMZ)
Palonosetron (PALO): Eligible patients should receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of daily temozolomide for a total of six weeks of treatment. For each week of radiation patients will receive a single 0.25 mg intravenous dose of palonosetron 30 minutes before each week of radiation fraction. This schedule will be repeated for each week of radiation for a total of 6 weeks.
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|---|---|
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Age, Continuous
|
58.9 years
STANDARD_DEVIATION 9.5 • n=5 Participants
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|
Sex: Female, Male
Female
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21 Participants
n=5 Participants
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Sex: Female, Male
Male
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17 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: 6 weeksThe number of participants with unacceptable toxicity defined as ≥grade 3, non-hematologic toxicities that are possibly, probably or definitely related to the study regimen.
Outcome measures
| Measure |
Palonosetron
n=38 Participants
Single Arm trial of Palonosetron for the prevention of RINV in primary malignant glioma patients receiving radiation therapy (RT) and concomitant temozolomide (TMZ)
Palonosetron (PALO): Eligible patients should receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of daily temozolomide for a total of six weeks of treatment. For each week of radiation patients will receive a single 0.25 mg intravenous dose of palonosetron 30 minutes before each week of radiation fraction. This schedule will be repeated for each week of radiation for a total of 6 weeks.
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|---|---|
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Safety and Tolerability of Palonosetron as Determined by the Number of Participants Who Experience Unacceptable Toxicity
|
5 participants
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SECONDARY outcome
Timeframe: 6 weeksThe percentage of participants with a complete response defined as no emetic episode or use of rescue medication while receiving radiation (XRT) and concomitant temozolomide (TMZ).
Outcome measures
| Measure |
Palonosetron
n=38 Participants
Single Arm trial of Palonosetron for the prevention of RINV in primary malignant glioma patients receiving radiation therapy (RT) and concomitant temozolomide (TMZ)
Palonosetron (PALO): Eligible patients should receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of daily temozolomide for a total of six weeks of treatment. For each week of radiation patients will receive a single 0.25 mg intravenous dose of palonosetron 30 minutes before each week of radiation fraction. This schedule will be repeated for each week of radiation for a total of 6 weeks.
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|---|---|
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Complete Response
Overall (across weeks 1-6 of XRT and TMZ) (N=34)
|
44 percentage of participants
Interval 27.0 to 62.0
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Complete Response
Week 1 of XRT and TMZ (n=38)
|
74 percentage of participants
Interval 57.0 to 87.0
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|
Complete Response
Week 2 of XRT and TMZ (n=38)
|
79 percentage of participants
Interval 63.0 to 90.0
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|
Complete Response
Week 3 of XRT and TMZ (n=38)
|
76 percentage of participants
Interval 60.0 to 89.0
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|
Complete Response
Week 4 of XRT and TMZ (n=38)
|
74 percentage of participants
Interval 57.0 to 87.0
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|
Complete Response
Week 5 of XRT and TMZ (n=36)
|
67 percentage of participants
Interval 49.0 to 81.0
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|
Complete Response
Week 6 of XRT and TMZ (n=34)
|
71 percentage of participants
Interval 53.0 to 85.0
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SECONDARY outcome
Timeframe: 6 weeksThe FLIE is a 18-item validated questionnaire for assessing the effects of chemotherapy-induced nausea and emesis on quality of life and daily functioning. The raw score range is 18-126 with higher scores indicating better quality of life. For each week of XRT and TMZ, the change from baseline was calculated by subtracting the baseline score from the mean of the day 1, 3 and 6 scores. A negative change represents worsening in quality of life due to nausea and emesis.
Outcome measures
| Measure |
Palonosetron
n=38 Participants
Single Arm trial of Palonosetron for the prevention of RINV in primary malignant glioma patients receiving radiation therapy (RT) and concomitant temozolomide (TMZ)
Palonosetron (PALO): Eligible patients should receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of daily temozolomide for a total of six weeks of treatment. For each week of radiation patients will receive a single 0.25 mg intravenous dose of palonosetron 30 minutes before each week of radiation fraction. This schedule will be repeated for each week of radiation for a total of 6 weeks.
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|---|---|
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Change in the Functional Living Index - Emesis (FLIE) Score From Baseline to Each Week of Radiation (XRT) and Temozolomide (TMZ) Treatment
Week 1 of XRT and TMZ (n=38)
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-3.3 units on a scale
Interval -6.8 to 0.2
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Change in the Functional Living Index - Emesis (FLIE) Score From Baseline to Each Week of Radiation (XRT) and Temozolomide (TMZ) Treatment
Week 2 of XRT and TMZ (n=38)
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-2.7 units on a scale
Interval -5.9 to 0.4
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Change in the Functional Living Index - Emesis (FLIE) Score From Baseline to Each Week of Radiation (XRT) and Temozolomide (TMZ) Treatment
Week 3 of XRT and TMZ (n=38)
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-1.9 units on a scale
Interval -4.1 to 0.3
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Change in the Functional Living Index - Emesis (FLIE) Score From Baseline to Each Week of Radiation (XRT) and Temozolomide (TMZ) Treatment
Week 4 of XRT and TMZ (n=38)
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-3.9 units on a scale
Interval -8.1 to 0.3
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Change in the Functional Living Index - Emesis (FLIE) Score From Baseline to Each Week of Radiation (XRT) and Temozolomide (TMZ) Treatment
Week 5 of XRT and TMZ (n=36)
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-5.5 units on a scale
Interval -11.0 to -0.1
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Change in the Functional Living Index - Emesis (FLIE) Score From Baseline to Each Week of Radiation (XRT) and Temozolomide (TMZ) Treatment
Week 6 of XRT and TMZ (n=34)
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-4.1 units on a scale
Interval -7.5 to -0.7
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SECONDARY outcome
Timeframe: 6 weeksPercentage of participants with a Osoba nausea module maximum standardized score of zero for each week of radiation (XRT) and Temozolomide (TMZ). The Osoba nausea module is a 5-item questionnaire assessing the effect of nausea on quality of life and daily functioning. Raw scores range from 5-20 and have been converted to standardized scores (0-100) using the formula: std\_score = round((raw\_score - 5) \* 6.66). Lower scores indicate better quality fo life. The maximum standardized score of all nausea scores collected during the week (days 1, 3 and 6) was used for this outcome.
Outcome measures
| Measure |
Palonosetron
n=38 Participants
Single Arm trial of Palonosetron for the prevention of RINV in primary malignant glioma patients receiving radiation therapy (RT) and concomitant temozolomide (TMZ)
Palonosetron (PALO): Eligible patients should receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of daily temozolomide for a total of six weeks of treatment. For each week of radiation patients will receive a single 0.25 mg intravenous dose of palonosetron 30 minutes before each week of radiation fraction. This schedule will be repeated for each week of radiation for a total of 6 weeks.
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|---|---|
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Percentage of Participants With a Osoba Nausea Module Maximum Standardized Score of Zero for Each Week of Radiation (XRT) and Temozolomide (TMZ)
Week 1 of XRT and TMZ (n=38)
|
76 percentage of participants
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Percentage of Participants With a Osoba Nausea Module Maximum Standardized Score of Zero for Each Week of Radiation (XRT) and Temozolomide (TMZ)
Week 3 of XRT and TMZ (n=38)
|
79 percentage of participants
|
|
Percentage of Participants With a Osoba Nausea Module Maximum Standardized Score of Zero for Each Week of Radiation (XRT) and Temozolomide (TMZ)
Week 4 of XRT and TMZ (n=38)
|
79 percentage of participants
|
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Percentage of Participants With a Osoba Nausea Module Maximum Standardized Score of Zero for Each Week of Radiation (XRT) and Temozolomide (TMZ)
Week 5 of XRT and TMZ (n=35)
|
71 percentage of participants
|
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Percentage of Participants With a Osoba Nausea Module Maximum Standardized Score of Zero for Each Week of Radiation (XRT) and Temozolomide (TMZ)
Week 2 of XRT and TMZ (n=38)
|
79 percentage of participants
|
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Percentage of Participants With a Osoba Nausea Module Maximum Standardized Score of Zero for Each Week of Radiation (XRT) and Temozolomide (TMZ)
Week 6 of XRT and TMZ (n=34)
|
79 percentage of participants
|
SECONDARY outcome
Timeframe: 6 weeksPercentage of participants with a Osoba vomiting/retching module maximum standardized score of zero for each week of radiation (XRT) and Temozolomide (TMZ). The Osoba vomiting/retching module is a 5-item questionnaire assessing the effect of vomiting/retching on quality of life and daily functioning. Raw scores range from 5-20 and have been converted to standardized scores (0-100) using the formula: std\_score = round((raw\_score - 5) \* 6.66). Lower scores indicate better quality fo life. The maximum standardized score of all vomiting/retching scores collected during the week (days 1, 3 and 6) was used for this outcome.
Outcome measures
| Measure |
Palonosetron
n=38 Participants
Single Arm trial of Palonosetron for the prevention of RINV in primary malignant glioma patients receiving radiation therapy (RT) and concomitant temozolomide (TMZ)
Palonosetron (PALO): Eligible patients should receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of daily temozolomide for a total of six weeks of treatment. For each week of radiation patients will receive a single 0.25 mg intravenous dose of palonosetron 30 minutes before each week of radiation fraction. This schedule will be repeated for each week of radiation for a total of 6 weeks.
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|---|---|
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Percentage of Participants With a Osoba Vomiting/Retching Module Maximum Standardized Score of Zero for Each Week of Radiation (XRT) and Temozolomide (TMZ)
Week 1 of XRT and TMZ (n=38)
|
87 percentage of participants
|
|
Percentage of Participants With a Osoba Vomiting/Retching Module Maximum Standardized Score of Zero for Each Week of Radiation (XRT) and Temozolomide (TMZ)
Week 2 of XRT and TMZ (n=38)
|
89 percentage of participants
|
|
Percentage of Participants With a Osoba Vomiting/Retching Module Maximum Standardized Score of Zero for Each Week of Radiation (XRT) and Temozolomide (TMZ)
Week 4 of XRT and TMZ (n=38)
|
92 percentage of participants
|
|
Percentage of Participants With a Osoba Vomiting/Retching Module Maximum Standardized Score of Zero for Each Week of Radiation (XRT) and Temozolomide (TMZ)
Week 5 of XRT and TMZ (n=35)
|
89 percentage of participants
|
|
Percentage of Participants With a Osoba Vomiting/Retching Module Maximum Standardized Score of Zero for Each Week of Radiation (XRT) and Temozolomide (TMZ)
Week 6 of XRT and TMZ (n=34)
|
97 percentage of participants
|
|
Percentage of Participants With a Osoba Vomiting/Retching Module Maximum Standardized Score of Zero for Each Week of Radiation (XRT) and Temozolomide (TMZ)
Week 3 of XRT and TMZ (n=38)
|
100 percentage of participants
|
Adverse Events
Palonosetron
Serious events: 5 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Palonosetron
n=38 participants at risk
Single Arm trial of Palonosetron for the prevention of RINV in primary malignant glioma patients receiving radiation therapy (RT) and concomitant temozolomide (TMZ)
Palonosetron (PALO): Eligible patients should receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of daily temozolomide for a total of six weeks of treatment. For each week of radiation patients will receive a single 0.25 mg intravenous dose of palonosetron 30 minutes before each week of radiation fraction. This schedule will be repeated for each week of radiation for a total of 6 weeks.
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|---|---|
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Cardiac disorders
Atrial fibrillation
|
2.6%
1/38 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
General disorders
Edema face
|
2.6%
1/38 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
2.6%
1/38 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
2.6%
1/38 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Nervous system disorders
Headache
|
2.6%
1/38 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.6%
1/38 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.6%
1/38 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Vascular disorders
Thromboembolic event
|
2.6%
1/38 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
Other adverse events
| Measure |
Palonosetron
n=38 participants at risk
Single Arm trial of Palonosetron for the prevention of RINV in primary malignant glioma patients receiving radiation therapy (RT) and concomitant temozolomide (TMZ)
Palonosetron (PALO): Eligible patients should receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of daily temozolomide for a total of six weeks of treatment. For each week of radiation patients will receive a single 0.25 mg intravenous dose of palonosetron 30 minutes before each week of radiation fraction. This schedule will be repeated for each week of radiation for a total of 6 weeks.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
5.3%
2/38 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Eye disorders
Blurred vision
|
39.5%
15/38 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Gastrointestinal disorders
Constipation
|
55.3%
21/38 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Gastrointestinal disorders
Diarrhea
|
21.1%
8/38 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
2.6%
1/38 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Gastrointestinal disorders
Ileus
|
2.6%
1/38 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Gastrointestinal disorders
Mucositis oral
|
21.1%
8/38 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Gastrointestinal disorders
Nausea
|
42.1%
16/38 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Gastrointestinal disorders
Vomiting
|
23.7%
9/38 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
General disorders
Edema limbs
|
7.9%
3/38 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
General disorders
Fatigue
|
55.3%
21/38 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
General disorders
Fever
|
5.3%
2/38 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
28.9%
11/38 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Infections and infestations
Wound infection
|
2.6%
1/38 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Investigations
Alanine aminotransferase increased
|
7.9%
3/38 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Investigations
Alkaline phosphatase increased
|
2.6%
1/38 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Investigations
Aspartate aminotransferase increased
|
2.6%
1/38 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Investigations
Blood bilirubin increased
|
5.3%
2/38 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Investigations
Investigations - Other, specify
|
2.6%
1/38 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Investigations
Platelet count decreased
|
15.8%
6/38 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Investigations
Weight loss
|
18.4%
7/38 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Metabolism and nutrition disorders
Anorexia
|
31.6%
12/38 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
18.4%
7/38 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
2.6%
1/38 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
2.6%
1/38 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.6%
1/38 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.6%
1/38 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
10.5%
4/38 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Nervous system disorders
Ataxia
|
28.9%
11/38 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Nervous system disorders
Cognitive disturbance
|
42.1%
16/38 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Nervous system disorders
Depressed level of consciousness
|
39.5%
15/38 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Nervous system disorders
Dizziness
|
34.2%
13/38 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Nervous system disorders
Dysphasia
|
10.5%
4/38 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Nervous system disorders
Headache
|
50.0%
19/38 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Nervous system disorders
Memory impairment
|
39.5%
15/38 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
39.5%
15/38 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
21.1%
8/38 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Nervous system disorders
Seizure
|
7.9%
3/38 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Nervous system disorders
Tremor
|
13.2%
5/38 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Psychiatric disorders
Confusion
|
36.8%
14/38 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Psychiatric disorders
Depression
|
47.4%
18/38 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Psychiatric disorders
Insomnia
|
44.7%
17/38 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Renal and urinary disorders
Urinary incontinence
|
15.8%
6/38 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify
|
23.7%
9/38 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
23.7%
9/38 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
15.8%
6/38 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
23.7%
9/38 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Institution will provide Eisai with a copy of any manuscript, paper, or poster connected with the study at least 30 days prior to submission to journal/presentation in order for Eisai to review for Eisai's Confidential Information (CI). Should Eisai notify Institution with such 30 day period that materials contain CI, Institution agrees to delay submission/publication/presentation for an additional 60 days to allow Eisai to seek patent or other protection.
- Publication restrictions are in place
Restriction type: OTHER