Exploratory Study, Evaluating the Treatment Effect of Surgery Plus GLIADEL® Wafer in Patients With Metastatic Brain Cancer
Sponsor
Eisai Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00525590
Collaborator
(none)
69
17
1
35.6
4.1
0.1
Study Details
Study Description
Brief Summary
The purpose of this study is to determine the effect of the surgical intervention and insertion of GLIADEL wafers on the neurocognitive functioning in patients with metastatic brain cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
69 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Multicenter, Exploratory Study, Evaluating the Treatment Effect of Surgery Plus GLIADEL® Wafer in Patients With Metastatic Brain Cancer
Actual Study Start Date
:
Dec 12, 2007
Actual Primary Completion Date
:
Dec 1, 2010
Actual Study Completion Date
:
Dec 1, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1
|
Drug: GLIADEL
Resect the tumor as completely as possible. After repeated irrigation of the decompressed area demonstrates no bleeding, and care is taken not to have any foreign material enter the ventricle, up to 8 GLIADEL wafers should be placed to cover the entire surface area of the resection cavity (if possible). Slight overlapping of wafer edges is permitted. The number of wafers will be determined by the size of the tumor resection cavity. Each GLIADEL wafer contains 7.7 mg of carmustine, resulting in a dose of 61.6 mg when 8 wafers are implanted. The GLIADEL wafer is a round white to yellow disk with flat surfaces.
|
Outcome Measures
Primary Outcome Measures
- Rate of Deterioration in Neurocognitive Functioning (NF) at Month 12 [Month 12]
NF was assessed as the performance of 3 neurocognitive domains:memory(MD),executive function(EFD), fine motor coordination(FMCD). For each domain, z-scores were derived from participant's scores in individual neurocognitive tests using an age-adjusted and education-adjusted normative distribution of scores from an unimpaired population.Individual z-scores from related tests were averaged to determine overall z-score.If a z-score average decreased from baseline by greater than or equal to(>=)3 standard deviations(SD)in tests' normative age-adjusted distribution on 2 consecutive visits or decreased by >=3 SD on last follow-up visit, participant were considered to have significant deterioration in their NF at time of the first decrease in z-score.Deterioration in NF:demonstrated deterioration for at least two of the three neurocognitive domains based on these changes from screening.Rate of deterioration in NF was measured as estimated percentage of participants using Kaplan-Meier method.
- Number of Participants With Neurocognitive Domains Preserved at Month 2 [Month 2]
Preservation of NF was defined as a decrease of <=1 SD, any increase, or no change (0 SD) in z-score for each domain (memory domain, executive function domain, and fine motor coordination domain).
- Number of Participants With Neurocognitive Domains Preserved at Month 4 [Month 4]
Preservation of NF was defined as a decrease of <=1 SD, any increase, or no change (0 SD) in z-score for each domain (memory domain, executive function domain, and fine motor coordination domain).
- Number of Participants With Neurocognitive Domains Preserved at Month 6 [Month 6]
Preservation of NF was defined as a decrease of <=1 SD, any increase, or no change (0 SD) in z-score for each domain (memory domain, executive function domain, and fine motor coordination domain).
- Number of Participants With Neurocognitive Domains Preserved at Month 9 [Month 9]
Preservation of NF was defined as a decrease of <=1 SD, any increase, or no change (0 SD) in z-score for each domain (memory domain, executive function domain, and fine motor coordination domain).
- Number of Participants With Neurocognitive Domains Preserved at Month 12 [Month 12]
Preservation of NF was defined as a decrease of less than or equal to (<=) 1 SD, any increase, or no change (0 SD) in z-score for each domain (memory domain, executive function domain, and fine motor coordination domain).
Secondary Outcome Measures
- Percentage of Participants With Brain Tumor Recurrence (Local Recurrence, Distant Recurrence and Overall Recurrence) [Up to Month 12 (from baseline until evidence of neurological deterioration, had a local recurrence, withdrawn, died, lost to follow-up, or the study was closed)]
- Time to Recurrence (Local, Distant and Overall) [Up to Month 12 (from baseline until evidence of neurological deterioration, had a local recurrence, withdrawn, died, lost to follow-up, or the study was closed)]
- Correlation of Tumor Recurrence With Residual Mass Effect [Up to Month 12 (from baseline until evidence of neurological deterioration, had a local recurrence, withdrawn, died, lost to follow-up, or the study was closed)]
- Correlation of Tumor Recurrence (Local, Distant or Overall) With NF Domain Scores [Up to Month 12 (from baseline until evidence of neurological deterioration, had a local recurrence, withdrawn, died, lost to follow-up, or the study was closed)]
The correlation between recurrence (local, distant or overall) & NF was assessed by presenting change in NF domain scores (memory domain [MD], executive function domain [EFD], fine motor coordination domain [FMCD]) after tumor recurrence (Visits X, X+1, X+2, and X+3) compared to before tumor recurrence (Visit X-1). Here 'Visit X' refers to visit at which participants had tumor recurrence, Visit X-1 refers to visit immediately before the recurrence and X+1, X+2, X+3 refers to subsequent first, second & third visit after the recurrence.NF domain z-scores were derived from participant's scores in individual neurocognitive tests using an age-adjusted &education-adjusted normative distribution of scores from an unimpaired population. Individual z-scores from related tests were averaged to determine overall z-score for each of NF domains.
- Percentage of Participants With Neurologic Death [Up to Month 12 (from baseline until evidence of neurological deterioration, had a local recurrence, withdrawn, died, lost to follow-up, or the study was closed)]
Neurologic Death was defined as death due to progression of neurologic disease.
- Time to Neurocognitive Deterioration [Up to Month 12 (from baseline until evidence of neurological deterioration, had a local recurrence, withdrawn, died, lost to follow-up, or the study was closed)]
The time to neurocognitive deterioration was defined as the number of days between the date of study treatment and the date of neurocognitive deterioration based on NF assessment. This was assessed using Kaplan Meier method.
- Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) [Months 2, 4, 6, 9 and 12]
Neurocognitive decline was defined as any decrease in NF scores less than (<) 0 SD from baseline. Here, in category titles EFD represents Executive Function Domain and FMCD represents Fine Motor Coordination Domain.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Can provide signed/dated Informed Consent, and Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization.
-
Are a male or female patient 18 years of age or older.
-
Are willing to a use barrier method of contraception if fertile or of childbearing potential until 30 days after surgical resection. If the patient receives subsequent chemotherapy during study participation (as allowed by the protocol), appropriate contraception will be managed by the principal investigator.
-
Have a primary diagnosis of solid-based tumor cancer (except small cell lung cancer (SCLS), lymphoma, germ cell cancer or anaplastic thyroid cancer) or unknown primary cancer and have 1-3 brain metastasis(es) for which surgical resection is planned for a single metastasis and any remaining metastases are planned for stereotactic radiosurgery (SRS);
OR
an intra-operative diagnosis of metastatic brain tumor in a patient with a single brain lesion.
-
Have a life expectancy of ≥12 weeks.
-
Have a Karnofsky Performance Status (KPS) score of 70 or higher.
-
Have Recursive Partitioning Analysis (RPA) status of 1 or 2.
-
Women of childbearing potential must have a negative serum or urine pregnancy test within 14 days of the surgical resection; and
-
Patients must be able to understand English, either orally or in writing, and be able to consent and complete the required assessments and procedures.
Exclusion Criteria:
-
Are unable or unwilling to understand study assessment or to cooperate with the study procedures as determined by the investigator.
-
Have a history of allergic reaction or known hypersensitivity to BCNU (carmustine) or other components of the GLIADEL, such as polifeprosan polymer.
-
Have a history of prior cranial irradiation.
-
Have a prior diagnosis of Central Nervous System (CNS) tumor.
-
Have received prior treatment for brain tumors.
-
Have had prior exposure to GLIADEL or its components, such as polifeprosan polymer.
-
Have any uncontrolled medical or psychiatric conditions which preclude them from participating in or completing the study procedures.
-
Concurrent severe medical conditions include, but are not limited to, active infection, acute hepatitis, cardiac arrhythmia, unstable angina, congestive heart failure, uncontrolled diabetes mellitus, uncontrolled seizures, pulmonary insufficiency, pulmonary fibrosis, pulmonary embolus, etc.
-
Have a diagnosis of tumor in the brain stem or posterior fossa.
-
Have an RPA status of 3.
-
Have a diagnosis of leptomeningeal disease at time of enrollment; or
-
Are currently pregnant or lactating, or plan to become pregnant during the course of the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Arizona / University Medical Center | Tucson | Arizona | United States | 85724 |
| 2 | University of California, Los Angeles | Los Angeles | California | United States | 90095 |
| 3 | University of South Florida | Tampa | Florida | United States | 33606 |
| 4 | H. Lee Moffitt Cancer Center & Research Institute | Tampa | Florida | United States | 33612 |
| 5 | The University of Chicago | Chicago | Illinois | United States | 60637 |
| 6 | NorthShore University HealthSystem Reseach Institute | Evanston | Illinois | United States | 60201 |
| 7 | University of Iowa Hospitals and Clinics | Iowa City | Iowa | United States | 52242 |
| 8 | Weill Medical College Department of Neurological Surgery | New York | New York | United States | 10021 |
| 9 | University of North Carolina | Chapel Hill | North Carolina | United States | 27599 |
| 10 | Carolina Neurosurgery & Spine Associates | Charlotte | North Carolina | United States | 28204 |
| 11 | Cleveland Clinic | Cleveland | Ohio | United States | 44195 |
| 12 | The Ohio State University Medical Center | Columbus | Ohio | United States | 43210 |
| 13 | Temple University | Philadelphia | Pennsylvania | United States | 19140 |
| 14 | Methodist University Hospital | Memphis | Tennessee | United States | 38104 |
| 15 | Vanderbilt University Medical Center | Nashville | Tennessee | United States | 37232 |
| 16 | UT Southwestern Medical Center at Dallas | Dallas | Texas | United States | 75390 |
| 17 | Trinity Mother Frances Health System | Tyler | Texas | United States | 75702 |
Sponsors and Collaborators
- Eisai Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00525590
Other Study ID Numbers:
- GLIA-001
First Posted:
Sep 6, 2007
Last Update Posted:
Mar 16, 2020
Last Verified:
Feb 1, 2020
Study Results
Participant Flow
| Recruitment Details | Participants took part in the study at 12 sites in the United States from 12 December 2007 to 01 December 2010. |
|---|---|
| Pre-assignment Detail | A total of 82 participants with metastatic brain cancer were screened, of which 69 participants were enrolled and 59 participants were treated. |
| Arm/Group Title | GLIADEL |
|---|---|
| Arm/Group Description | Participants with metastatic brain tumors who underwent neurosurgical resection of their lesions were implanted with up to 8 GLIADEL wafers in their tumor cavities (each containing 7.7 [milligram] mg of carmustine). Participants were followed up to 12 months or until the participant experienced local recurrence, withdrew, died, was lost to follow-up, or the study was closed. |
| Period Title: Overall Study | |
| STARTED | 59 |
| COMPLETED | 14 |
| NOT COMPLETED | 45 |
Baseline Characteristics
| Arm/Group Title | GLIADEL |
|---|---|
| Arm/Group Description | Participants with metastatic brain tumors who underwent neurosurgical resection of their lesions were implanted with up to 8 GLIADEL wafers in their tumor cavities (each containing 7.7 mg of carmustine). Participants were followed up to 12 months or until the participant experienced local recurrence, withdrew, died, was lost to follow-up, or the study was closed. |
| Overall Participants | 59 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
62.0
(11.60)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
33
55.9%
|
| Male |
26
44.1%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
0
0%
|
| Not Hispanic or Latino |
59
100%
|
| Unknown or Not Reported |
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
1
1.7%
|
| Asian |
2
3.4%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
1
1.7%
|
| White |
55
93.2%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
0
0%
|
Outcome Measures
| Title | Rate of Deterioration in Neurocognitive Functioning (NF) at Month 12 |
|---|---|
| Description | NF was assessed as the performance of 3 neurocognitive domains:memory(MD),executive function(EFD), fine motor coordination(FMCD). For each domain, z-scores were derived from participant's scores in individual neurocognitive tests using an age-adjusted and education-adjusted normative distribution of scores from an unimpaired population.Individual z-scores from related tests were averaged to determine overall z-score.If a z-score average decreased from baseline by greater than or equal to(>=)3 standard deviations(SD)in tests' normative age-adjusted distribution on 2 consecutive visits or decreased by >=3 SD on last follow-up visit, participant were considered to have significant deterioration in their NF at time of the first decrease in z-score.Deterioration in NF:demonstrated deterioration for at least two of the three neurocognitive domains based on these changes from screening.Rate of deterioration in NF was measured as estimated percentage of participants using Kaplan-Meier method. |
| Time Frame | Month 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The per protocol 1 (PP1) population included all participants who received surgery plus GLIADEL, had an intra-operative diagnosis confirmed by permanent pathology findings, remained compliant with protocol procedures, and did not receive disallowed concomitant therapies (example whole brain radiation therapy [WBRT]) before recurrence. |
| Arm/Group Title | GLIADEL |
|---|---|
| Arm/Group Description | Participants with metastatic brain tumors who underwent neurosurgical resection of their lesions were implanted with up to 8 GLIADEL wafers in their tumor cavities (each containing 7.7 mg of carmustine). |
| Measure Participants | 54 |
| Number (95% Confidence Interval) [percentage of participants] |
2.8
4.7%
|
| Title | Number of Participants With Neurocognitive Domains Preserved at Month 2 |
|---|---|
| Description | Preservation of NF was defined as a decrease of <=1 SD, any increase, or no change (0 SD) in z-score for each domain (memory domain, executive function domain, and fine motor coordination domain). |
| Time Frame | Month 2 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PP1 population included all participants who received surgery plus GLIADEL, had an intra-operative diagnosis confirmed by permanent pathology findings, remained compliant with protocol procedures, and did not receive disallowed concomitant therapies (example WBRT) before recurrence. |
| Arm/Group Title | GLIADEL |
|---|---|
| Arm/Group Description | Participants with metastatic brain tumors who underwent neurosurgical resection of their lesions were implanted with up to 8 GLIADEL wafers in their tumor cavities (each containing 7.7 mg of carmustine). |
| Measure Participants | 54 |
| Domains preserved=3 |
26
44.1%
|
| Domains preserved=2 |
12
20.3%
|
| Domains preserved=1 |
4
6.8%
|
| Domains preserved=0 |
3
5.1%
|
| Title | Number of Participants With Neurocognitive Domains Preserved at Month 4 |
|---|---|
| Description | Preservation of NF was defined as a decrease of <=1 SD, any increase, or no change (0 SD) in z-score for each domain (memory domain, executive function domain, and fine motor coordination domain). |
| Time Frame | Month 4 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PP1 population included all participants who received surgery plus GLIADEL, had an intra-operative diagnosis confirmed by permanent pathology findings, remained compliant with protocol procedures, and did not receive disallowed concomitant therapies (example WBRT) before recurrence. |
| Arm/Group Title | GLIADEL |
|---|---|
| Arm/Group Description | Participants with metastatic brain tumors who underwent neurosurgical resection of their lesions were implanted with up to 8 GLIADEL wafers in their tumor cavities (each containing 7.7 mg of carmustine). |
| Measure Participants | 54 |
| Domains preserved=3 |
24
40.7%
|
| Domains preserved=2 |
9
15.3%
|
| Domains preserved=1 |
2
3.4%
|
| Domains preserved=0 |
1
1.7%
|
| Title | Number of Participants With Neurocognitive Domains Preserved at Month 6 |
|---|---|
| Description | Preservation of NF was defined as a decrease of <=1 SD, any increase, or no change (0 SD) in z-score for each domain (memory domain, executive function domain, and fine motor coordination domain). |
| Time Frame | Month 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PP1 population included all participants who received surgery plus GLIADEL, had an intra-operative diagnosis confirmed by permanent pathology findings, remained compliant with protocol procedures, and did not receive disallowed concomitant therapies (example WBRT) before recurrence. |
| Arm/Group Title | GLIADEL |
|---|---|
| Arm/Group Description | Participants with metastatic brain tumors who underwent neurosurgical resection of their lesions were implanted with up to 8 GLIADEL wafers in their tumor cavities (each containing 7.7 mg of carmustine). |
| Measure Participants | 54 |
| Domains preserved=3 |
17
28.8%
|
| Domains preserved=2 |
5
8.5%
|
| Domains preserved=1 |
2
3.4%
|
| Domains preserved=0 |
0
0%
|
| Title | Number of Participants With Neurocognitive Domains Preserved at Month 9 |
|---|---|
| Description | Preservation of NF was defined as a decrease of <=1 SD, any increase, or no change (0 SD) in z-score for each domain (memory domain, executive function domain, and fine motor coordination domain). |
| Time Frame | Month 9 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PP1 population included all participants who received surgery plus GLIADEL, had an intra-operative diagnosis confirmed by permanent pathology findings, remained compliant with protocol procedures, and did not receive disallowed concomitant therapies (example WBRT) before recurrence. |
| Arm/Group Title | GLIADEL |
|---|---|
| Arm/Group Description | Participants with metastatic brain tumors who underwent neurosurgical resection of their lesions were implanted with up to 8 GLIADEL wafers in their tumor cavities (each containing 7.7 mg of carmustine). |
| Measure Participants | 54 |
| Domains preserved=3 |
14
23.7%
|
| Domains preserved=2 |
6
10.2%
|
| Domains preserved=1 |
0
0%
|
| Domains preserved=0 |
0
0%
|
| Title | Number of Participants With Neurocognitive Domains Preserved at Month 12 |
|---|---|
| Description | Preservation of NF was defined as a decrease of less than or equal to (<=) 1 SD, any increase, or no change (0 SD) in z-score for each domain (memory domain, executive function domain, and fine motor coordination domain). |
| Time Frame | Month 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PP1 population included all participants who received surgery plus GLIADEL, had an intra-operative diagnosis confirmed by permanent pathology findings, remained compliant with protocol procedures, and did not receive disallowed concomitant therapies (example WBRT) before recurrence. |
| Arm/Group Title | GLIADEL |
|---|---|
| Arm/Group Description | Participants with metastatic brain tumors who underwent neurosurgical resection of their lesions were implanted with up to 8 GLIADEL wafers in their tumor cavities (each containing 7.7 mg of carmustine). |
| Measure Participants | 54 |
| Domains preserved=3 |
9
15.3%
|
| Domains preserved=2 |
5
8.5%
|
| Domains preserved=1 |
0
0%
|
| Domains preserved=0 |
0
0%
|
| Title | Percentage of Participants With Brain Tumor Recurrence (Local Recurrence, Distant Recurrence and Overall Recurrence) |
|---|---|
| Description | |
| Time Frame | Up to Month 12 (from baseline until evidence of neurological deterioration, had a local recurrence, withdrawn, died, lost to follow-up, or the study was closed) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PP1 population included all participants who received surgery plus GLIADEL, had an intra-operative diagnosis confirmed by permanent pathology findings, remained compliant with protocol procedures, and did not receive disallowed concomitant therapies (example WBRT) before recurrence. |
| Arm/Group Title | GLIADEL |
|---|---|
| Arm/Group Description | Participants with metastatic brain tumors who underwent neurosurgical resection of their lesions were implanted with up to 8 GLIADEL wafers in their tumor cavities (each containing 7.7 mg of carmustine). |
| Measure Participants | 54 |
| Local Recurrence |
28.0
47.5%
|
| Distant Recurrence |
48.0
81.4%
|
| Overall Recurrence |
62.0
105.1%
|
| Title | Time to Recurrence (Local, Distant and Overall) |
|---|---|
| Description | |
| Time Frame | Up to Month 12 (from baseline until evidence of neurological deterioration, had a local recurrence, withdrawn, died, lost to follow-up, or the study was closed) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PP1 population included all participants who received surgery plus GLIADEL, had an intra-operative diagnosis confirmed by permanent pathology findings, remained compliant with protocol procedures, and did not receive disallowed concomitant therapies (example WBRT) before recurrence. |
| Arm/Group Title | GLIADEL |
|---|---|
| Arm/Group Description | Participants with metastatic brain tumors who underwent neurosurgical resection of their lesions were implanted with up to 8 GLIADEL wafers in their tumor cavities (each containing 7.7 mg of carmustine). |
| Measure Participants | 54 |
| Time to Local Recurrence |
NA
|
| Time to Distant Recurrence |
8.5
|
| Time to Overall Recurrence |
6.1
|
| Title | Correlation of Tumor Recurrence With Residual Mass Effect |
|---|---|
| Description | |
| Time Frame | Up to Month 12 (from baseline until evidence of neurological deterioration, had a local recurrence, withdrawn, died, lost to follow-up, or the study was closed) |
Outcome Measure Data
| Analysis Population Description |
|---|
| PP1 population. Since only two participants had residual tumor mass, no correlation analyses were performed for recurrence and residual mass effect. |
| Arm/Group Title | GLIADEL |
|---|---|
| Arm/Group Description | Participants with metastatic brain tumors who underwent neurosurgical resection of their lesions were implanted with up to 8 GLIADEL wafers in their tumor cavities (each containing 7.7 mg of carmustine). |
| Measure Participants | 0 |
| Title | Correlation of Tumor Recurrence (Local, Distant or Overall) With NF Domain Scores |
|---|---|
| Description | The correlation between recurrence (local, distant or overall) & NF was assessed by presenting change in NF domain scores (memory domain [MD], executive function domain [EFD], fine motor coordination domain [FMCD]) after tumor recurrence (Visits X, X+1, X+2, and X+3) compared to before tumor recurrence (Visit X-1). Here 'Visit X' refers to visit at which participants had tumor recurrence, Visit X-1 refers to visit immediately before the recurrence and X+1, X+2, X+3 refers to subsequent first, second & third visit after the recurrence.NF domain z-scores were derived from participant's scores in individual neurocognitive tests using an age-adjusted &education-adjusted normative distribution of scores from an unimpaired population. Individual z-scores from related tests were averaged to determine overall z-score for each of NF domains. |
| Time Frame | Up to Month 12 (from baseline until evidence of neurological deterioration, had a local recurrence, withdrawn, died, lost to follow-up, or the study was closed) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PP1 population included all participants who received surgery plus GLIADEL, had an intra-operative diagnosis confirmed by permanent pathology findings, remained compliant with protocol procedures, and did not receive disallowed concomitant therapies (example WBRT) before recurrence. |
| Arm/Group Title | GLIADEL |
|---|---|
| Arm/Group Description | Participants with metastatic brain tumors who underwent neurosurgical resection of their lesions were implanted with up to 8 GLIADEL wafers in their tumor cavities (each containing 7.7 mg of carmustine). |
| Measure Participants | 54 |
| Local Recurrence: MD at Visit (X-1) |
-0.9
(1.21)
|
| Local Recurrence: MD Change at Visit (X-1) |
-1.1
(1.11)
|
| Local Recurrence: MD Change at Visit (X+1) |
0.7
(0.38)
|
| Local Recurrence: MD Change at Visit (X+2) |
0.1
(1.80)
|
| Local Recurrence: MD Change at Visit (X+3) |
-0.8
(NA)
|
| Local Recurrence: EFD at Visit (X-1) |
-0.4
(1.76)
|
| Local Recurrence: EFD Change at Visit (X-1) |
-0.5
(0.62)
|
| Local Recurrence: EFD Change at Visit (X+1) |
0.2
(0.89)
|
| Local Recurrence: EFD Change at Visit (X+2) |
-0.0
(0.74)
|
| Local Recurrence: EFD Change at Visit (X+3) |
-1.1
(NA)
|
| Local Recurrence: FMCD at Visit (X-1) |
-1.5
(1.65)
|
| Local Recurrence: FMCD Change at Visit (X-1) |
0.4
(0.59)
|
| Local Recurrence: FMCD Change at Visit (X+1) |
0.5
(0.53)
|
| Local Recurrence: FMCD Change at Visit (X+2) |
-0.4
(0.70)
|
| Local Recurrence: FMCD Change at Visit (X+3) |
0.3
(NA)
|
| Distant Recurrence: MD at Visit (X-1) |
-1.0
(1.04)
|
| Distant Recurrence: MD Change at Visit (X-1) |
0.2
(1.35)
|
| Distant Recurrence: MD Change at Visit (X+1) |
-0.2
(1.02)
|
| Distant Recurrence: MD Change at Visit (X+2) |
-0.2
(1.77)
|
| Distant Recurrence: MD Change at Visit (X+3) |
-0.7
(0.07)
|
| Distant Recurrence: EFD at Visit (X-1) |
-0.2
(1.44)
|
| Distant Recurrence: EFD Change at Visit (X-1) |
-0.2
(0.82)
|
| Distant Recurrence: EFD Change at Visit (X+1) |
-0.5
(1.11)
|
| Distant Recurrence: EFD Change at Visit (X+2) |
-0.8
(1.20)
|
| Distant Recurrence: EFD Change at Visit (X+3) |
-0.8
(0.39)
|
| Distant Recurrence: FMCD at Visit (X-1) |
-1.2
(1.32)
|
| Distant Recurrence: FMCD Change at Visit (X-1) |
-0.1
(0.61)
|
| Distant Recurrence: FMCD Change at Visit (X+1) |
-0.4
(0.99)
|
| Distant Recurrence: FMCD Change at Visit (X+2) |
-1.1
(1.03)
|
| Distant Recurrence: FMCD Change at Visit (X+3) |
-0.1
(0.48)
|
| Overall Recurrence: MD at Visit (X-1) |
-0.9
(1.15)
|
| Overall Recurrence: MD Change at Visit (X-1) |
-0.1
(1.40)
|
| Overall Recurrence: MD Change at Visit (X+1) |
-0.1
(0.96)
|
| Overall Recurrence: MD Change at Visit (X+2) |
-0.2
(1.67)
|
| Overall Recurrence: MD Change at Visit (X+3) |
-0.7
(0.07)
|
| Overall Recurrence: EFD at Visit (X-1) |
-0.1
(1.47)
|
| Overall Recurrence: EFD Change at Visit (X-1) |
-0.3
(0.76)
|
| Overall Recurrence: EFD Change at Visit (X+1) |
-0.5
(1.01)
|
| Overall Recurrence: EFD Change at Visit (X+2) |
-0.6
(0.98)
|
| Overall Recurrence: EFD Change at Visit (X+3) |
-0.8
(0.39)
|
| Overall Recurrence: FMCD at Visit (X-1) |
-1.2
(1.31)
|
| Overall Recurrence: FMCD Change at Visit (X-1) |
0.0
(0.69)
|
| Overall Recurrence: FMCD Change at Visit (X+1) |
-0.3
(0.92)
|
| Overall Recurrence: FMCD Change at Visit (X+2) |
-0.9
(0.95)
|
| Overall Recurrence: FMCD Change at Visit (X+3) |
-0.1
(0.48)
|
| Title | Percentage of Participants With Neurologic Death |
|---|---|
| Description | Neurologic Death was defined as death due to progression of neurologic disease. |
| Time Frame | Up to Month 12 (from baseline until evidence of neurological deterioration, had a local recurrence, withdrawn, died, lost to follow-up, or the study was closed) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PP1 population included all participants who received surgery plus GLIADEL, had an intra-operative diagnosis confirmed by permanent pathology findings, remained compliant with protocol procedures, and did not receive disallowed concomitant therapies (example WBRT) before recurrence. |
| Arm/Group Title | GLIADEL |
|---|---|
| Arm/Group Description | Participants with metastatic brain tumors who underwent neurosurgical resection of their lesions were implanted with up to 8 GLIADEL wafers in their tumor cavities (each containing 7.7 mg of carmustine). |
| Measure Participants | 54 |
| Number [percentage of participants] |
1.9
3.2%
|
| Title | Time to Neurocognitive Deterioration |
|---|---|
| Description | The time to neurocognitive deterioration was defined as the number of days between the date of study treatment and the date of neurocognitive deterioration based on NF assessment. This was assessed using Kaplan Meier method. |
| Time Frame | Up to Month 12 (from baseline until evidence of neurological deterioration, had a local recurrence, withdrawn, died, lost to follow-up, or the study was closed) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PP1 population included all participants who received surgery plus GLIADEL, had an intra-operative diagnosis confirmed by permanent pathology findings, remained compliant with protocol procedures, and did not receive disallowed concomitant therapies (example WBRT) before recurrence. |
| Arm/Group Title | GLIADEL |
|---|---|
| Arm/Group Description | Participants with metastatic brain tumors who underwent neurosurgical resection of their lesions were implanted with up to 8 GLIADEL wafers in their tumor cavities (each containing 7.7 mg of carmustine). |
| Measure Participants | 54 |
| Number (95% Confidence Interval) [months] |
NA
|
| Title | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) |
|---|---|
| Description | Neurocognitive decline was defined as any decrease in NF scores less than (<) 0 SD from baseline. Here, in category titles EFD represents Executive Function Domain and FMCD represents Fine Motor Coordination Domain. |
| Time Frame | Months 2, 4, 6, 9 and 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PP1 population included all participants who received surgery plus GLIADEL, had an intra-operative diagnosis confirmed by permanent pathology findings, remained compliant with protocol procedures, and did not receive disallowed concomitant therapies (example WBRT) before recurrence. |
| Arm/Group Title | GLIADEL |
|---|---|
| Arm/Group Description | Participants with metastatic brain tumors who underwent neurosurgical resection of their lesions were implanted with up to 8 GLIADEL wafers in their tumor cavities (each containing 7.7 mg of carmustine). |
| Measure Participants | 54 |
| Month 2: Memory Domain, decline <0 to -1 SD |
27.3
46.3%
|
| Month 2: Memory Domain, decline <-1 to -2 SD |
15.9
26.9%
|
| Month 2: Memory Domain, decline <-2 to -3 SD |
4.5
7.6%
|
| Month 2: Memory Domain, decline <-3 to -4 SD |
0
0%
|
| Month 2: Memory Domain, decline <-4 to -5 SD |
0
0%
|
| Month 2: Memory Domain, decline <-5 SD |
0
0%
|
| Month 2: EFD, decline <0 to -1 SD |
37.8
64.1%
|
| Month 2: EFD, decline <-1 to -2 SD |
8.1
13.7%
|
| Month 2: EFD, decline <-2 to -3 SD |
0
0%
|
| Month 2: EFD, decline <-3 to -4 SD |
0
0%
|
| Month 2: EFD, decline <-4 to -5 SD |
0
0%
|
| Month 2: EFD, decline <-5 SD |
0
0%
|
| Month 2: FMCD, decline <0 to -1 SD |
23.8
40.3%
|
| Month 2: FMCD, decline <-1 to -2 SD |
7.1
12%
|
| Month 2: FMCD, decline <-2 to -3 SD |
2.4
4.1%
|
| Month 2: FMCD, decline <-3 to -4 SD |
2.4
4.1%
|
| Month 2: FMCD, decline <-4 to -5 SD |
0
0%
|
| Month 2: FMCD, decline <-5 SD |
0
0%
|
| Month 4: Memory Domain, decline <0 to -1 SD |
19.4
32.9%
|
| Month 4: Memory Domain, decline <-1 to -2 SD |
8.3
14.1%
|
| Month 4: Memory Domain, decline <-2 to -3 SD |
0
0%
|
| Month 4: Memory Domain, decline <-3 to -4 SD |
0
0%
|
| Month 4: Memory Domain, decline <-4 to -5 SD |
2.8
4.7%
|
| Month 4: Memory Domain, decline <-5 SD |
2.8
4.7%
|
| Month 4: EFD, decline <0 to -1 SD |
29.0
49.2%
|
| Month 4: EFD, decline <-1 to -2 SD |
0
0%
|
| Month 4: EFD, decline <-2 to -3 SD |
0
0%
|
| Month 4: EFD, decline <-3 to -4 SD |
0
0%
|
| Month 4: EFD, decline <-4 to -5 SD |
0
0%
|
| Month 4: EFD, decline <-5 SD |
0
0%
|
| Month 4: FMCD, decline <0 to -1 SD |
17.1
29%
|
| Month 4: FMCD, decline <-1 to -2 SD |
11.4
19.3%
|
| Month 4: FMCD, decline <-2 to -3 SD |
0
0%
|
| Month 4: FMCD, decline <-3 to -4 SD |
2.9
4.9%
|
| Month 4: FMCD, decline <-4 to -5 SD |
0
0%
|
| Month 4: FMCD, decline <-5 SD |
0
0%
|
| Month 6: Memory Domain, decline <0 to -1 SD |
12.5
21.2%
|
| Month 6: Memory Domain, decline <-1 to -2 SD |
0
0%
|
| Month 6: Memory Domain, decline <-2 to -3 SD |
4.2
7.1%
|
| Month 6: Memory Domain, decline <-3 to -4 SD |
0
0%
|
| Month 6: Memory Domain, decline <-4 to -5 SD |
0
0%
|
| Month 6: Memory Domain, decline <-5 SD |
0
0%
|
| Month 6: EFD, decline <0 to -1 SD |
18.2
30.8%
|
| Month 6: EFD, decline <-1 to -2 SD |
4.5
7.6%
|
| Month 6: EFD, decline <-2 to -3 SD |
0
0%
|
| Month 6: EFD, decline <-3 to -4 SD |
0
0%
|
| Month 6: EFD, decline <-4 to -5 SD |
0
0%
|
| Month 6: EFD, decline <-5 SD |
0
0%
|
| Month 6: FMCD, decline <0 to -1 SD |
12.5
21.2%
|
| Month 6: FMCD, decline <-1 to -2 SD |
20.8
35.3%
|
| Month 6: FMCD, decline <-2 to -3 SD |
0
0%
|
| Month 6: FMCD, decline <-3 to -4 SD |
0
0%
|
| Month 6: FMCD, decline <-4 to -5 SD |
0
0%
|
| Month 6: FMCD, decline <-5 SD |
0
0%
|
| Month 9: Memory Domain, decline <0 to -1 SD |
25.0
42.4%
|
| Month 9: Memory Domain, decline <-1 to -2 SD |
5.0
8.5%
|
| Month 9: Memory Domain, decline <-2 to -3 SD |
0
0%
|
| Month 9: Memory Domain, decline <-3 to -4 SD |
0
0%
|
| Month 9: Memory Domain, decline <-4 to -5 SD |
0
0%
|
| Month 9: Memory Domain, decline <-5 SD |
0
0%
|
| Month 9: EFD, decline <0 to -1 SD |
36.8
62.4%
|
| Month 9: EFD, decline <-1 to -2 SD |
5.3
9%
|
| Month 9: EFD, decline <-2 to -3 SD |
0
0%
|
| Month 9: EFD, decline <-3 to -4 SD |
0
0%
|
| Month 9: EFD, decline <-4 to -5 SD |
0
0%
|
| Month 9: EFD, decline <-5 SD |
0
0%
|
| Month 9: FMCD, decline <0 to -1 SD |
20.0
33.9%
|
| Month 9: FMCD, decline <-1 to -2 SD |
10.0
16.9%
|
| Month 9: FMCD, decline <-2 to -3 SD |
5.0
8.5%
|
| Month 9: FMCD, decline <-3 to -4 SD |
0
0%
|
| Month 9: FMCD, decline <-4 to -5 SD |
0
0%
|
| Month 9: FMCD, decline <-5 SD |
0
0%
|
| Month 12: Memory Domain, decline <0 to -1 SD |
14.3
24.2%
|
| Month 12: Memory Domain, decline <-1 to -2 SD |
7.1
12%
|
| Month 12: Memory Domain, decline <-2 to -3 SD |
0
0%
|
| Month 12: Memory Domain, decline <-3 to -4 SD |
0
0%
|
| Month 12: Memory Domain, decline <-4 to -5 SD |
0
0%
|
| Month 12: Memory Domain, decline <-5 SD |
0
0%
|
| Month 12: EFD, decline <0 to -1 SD |
33.3
56.4%
|
| Month 12: EFD, decline <-1 to -2 SD |
0
0%
|
| Month 12: EFD, decline <-2 to -3 SD |
0
0%
|
| Month 12: EFD, decline <-3 to -4 SD |
0
0%
|
| Month 12: EFD, decline <-4 to -5 SD |
0
0%
|
| Month 12: EFD, decline <-5 SD |
0
0%
|
| Month 12: FMCD, decline <0 to -1 SD |
7.1
12%
|
| Month 12: FMCD, decline <-1 to -2 SD |
14.3
24.2%
|
| Month 12: FMCD, decline <-2 to -3 SD |
0
0%
|
| Month 12: FMCD, decline <-3 to -4 SD |
0
0%
|
| Month 12: FMCD, decline <-4 to -5 SD |
0
0%
|
| Month 12: FMCD, decline <-5 SD |
0
0%
|
Adverse Events
| Time Frame | Screening up to 12 months | |
|---|---|---|
| Adverse Event Reporting Description | The study team only has access to serious and all treatment-emergent adverse events (serious and non-serious). All efforts to locate other adverse event data have been exhausted. All treatment-emergent adverse events, whether serious or non-serious, have been reported in the Other (Not Including Serious) Adverse Events tables as severity of the event cannot be distinguished in available data. | |
| Arm/Group Title | GLIADEL | |
| Arm/Group Description | Participants with metastatic brain tumors who underwent neurosurgical resection of their lesions were implanted with up to 8 GLIADEL wafers in their tumor cavities (each containing 7.7 mg of carmustine). Participants were followed up to 12 months or until the participant experienced local recurrence, withdrew, died, was lost to follow-up, or the study was closed. | |
All Cause Mortality |
||
| GLIADEL | ||
| Affected / at Risk (%) | # Events | |
| Total | 9/59 (15.3%) | |
Serious Adverse Events |
||
| GLIADEL | ||
| Affected / at Risk (%) | # Events | |
| Total | 40/59 (67.8%) | |
| Cardiac disorders | ||
| Cardiac failure congestive | 1/59 (1.7%) | |
| Cardiopulmonary failure | 1/59 (1.7%) | |
| Endocrine disorders | ||
| Adrenal insufficiency | 1/59 (1.7%) | |
| Gastrointestinal disorders | ||
| Lip pain | 1/59 (1.7%) | |
| Nausea | 1/59 (1.7%) | |
| Vomiting | 1/59 (1.7%) | |
| General disorders | ||
| Asthenia | 2/59 (3.4%) | |
| Drug withdrawal syndrome | 1/59 (1.7%) | |
| Multi-organ failure | 1/59 (1.7%) | |
| Pyrexia | 1/59 (1.7%) | |
| Infections and infestations | ||
| Brain abscess | 1/59 (1.7%) | |
| Bronchitis | 1/59 (1.7%) | |
| Device related infection | 1/59 (1.7%) | |
| Pneumonia | 2/59 (3.4%) | |
| Wound infection | 1/59 (1.7%) | |
| Injury, poisoning and procedural complications | ||
| Haemothorax | 1/59 (1.7%) | |
| Wound dehiscence | 1/59 (1.7%) | |
| Investigations | ||
| Blood creatinine increased | 1/59 (1.7%) | |
| Metabolism and nutrition disorders | ||
| Dehydration | 3/59 (5.1%) | |
| Failure to thrive | 6/59 (10.2%) | |
| Hyponatraemia | 1/59 (1.7%) | |
| Musculoskeletal and connective tissue disorders | ||
| Muscular weakness | 1/59 (1.7%) | |
| Pathological fracture | 1/59 (1.7%) | |
| Soft tissue necrosis | 1/59 (1.7%) | |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Malignant neoplasm progression | 18/59 (30.5%) | |
| Metastases to adrenals | 1/59 (1.7%) | |
| Metastases to central nervous system | 7/59 (11.9%) | |
| Metastases to liver | 1/59 (1.7%) | |
| Metastases to lung | 1/59 (1.7%) | |
| Metastases to small intestine | 1/59 (1.7%) | |
| Neoplasm recurrence | 5/59 (8.5%) | |
| Nervous system disorders | ||
| Convulsion | 2/59 (3.4%) | |
| Headache | 2/59 (3.4%) | |
| Intracranial hypotension | 1/59 (1.7%) | |
| Visual field defect | 1/59 (1.7%) | |
| Psychiatric disorders | ||
| Agitation | 1/59 (1.7%) | |
| Anxiety | 1/59 (1.7%) | |
| Depression | 1/59 (1.7%) | |
| Mental status changes | 1/59 (1.7%) | |
| Renal and urinary disorders | ||
| Haematuria | 1/59 (1.7%) | |
| Respiratory, thoracic and mediastinal disorders | ||
| Acute respiratory distress syndrome | 1/59 (1.7%) | |
| Dyspnoea | 1/59 (1.7%) | |
| Haemoptysis | 1/59 (1.7%) | |
| Lung infiltration | 1/59 (1.7%) | |
| Pleural effusion | 1/59 (1.7%) | |
| Pneumothorax | 1/59 (1.7%) | |
| Pulmonary embolism | 2/59 (3.4%) | |
| Pulmonary haemorrhage | 1/59 (1.7%) | |
| Vascular disorders | ||
| Deep vein thrombosis | 5/59 (8.5%) | |
Other (Not Including Serious) Adverse Events |
||
| GLIADEL | ||
| Affected / at Risk (%) | # Events | |
| Total | 53/59 (89.8%) | |
| Blood and lymphatic system disorders | ||
| Anaemia | 3/59 (5.1%) | |
| Lymphadenopathy mediastinal | 1/59 (1.7%) | |
| Thrombocytopenia | 1/59 (1.7%) | |
| Cardiac disorders | ||
| Bradycardia | 3/59 (5.1%) | |
| Tachycardia | 1/59 (1.7%) | |
| Ventricular extrasystoles | 1/59 (1.7%) | |
| Eye disorders | ||
| Eye pain | 1/59 (1.7%) | |
| Lacrimation increased | 1/59 (1.7%) | |
| Vision blurred | 3/59 (5.1%) | |
| Vision disturbance | 1/59 (1.7%) | |
| Gastrointestinal disorders | ||
| Abdominal distension | 2/59 (3.4%) | |
| Abdominal pain | 1/59 (1.7%) | |
| Constipation | 9/59 (15.3%) | |
| Diarrhoea | 2/59 (3.4%) | |
| Duodenal ulcer | 1/59 (1.7%) | |
| Dyspepsia | 1/59 (1.7%) | |
| Dysphagia | 1/59 (1.7%) | |
| Faecal incontinence | 1/59 (1.7%) | |
| Gastritis | 1/59 (1.7%) | |
| Gastrooesophageal reflux disease | 2/59 (3.4%) | |
| Hypoaesthesia oral | 1/59 (1.7%) | |
| Loose tooth | 1/59 (1.7%) | |
| Nausea | 9/59 (15.3%) | |
| Oral soft tissue disorder | 1/59 (1.7%) | |
| Rectal discharge | 1/59 (1.7%) | |
| Vomiting | 4/59 (6.8%) | |
| General disorders | ||
| Asthenia | 7/59 (11.9%) | |
| Chest pain | 1/59 (1.7%) | |
| Drug withdrawal syndrome | 1/59 (1.7%) | |
| Fatigue | 13/59 (22%) | |
| Gait disturbance | 1/59 (1.7%) | |
| Hunger | 1/59 (1.7%) | |
| Irritability | 1/59 (1.7%) | |
| Non-cardiac chest pain | 1/59 (1.7%) | |
| Oedema peripheral | 6/59 (10.2%) | |
| Pyrexia | 5/59 (8.5%) | |
| Immune system disorders | ||
| Drug hypersensitivity | 1/59 (1.7%) | |
| Infections and infestations | ||
| Brain abscess | 1/59 (1.7%) | |
| Bronchitis | 1/59 (1.7%) | |
| Candidiasis | 3/59 (5.1%) | |
| Device related infection | 1/59 (1.7%) | |
| Escherichia urinary tract infection | 1/59 (1.7%) | |
| Herpes virus infection | 1/59 (1.7%) | |
| Laryngitis | 1/59 (1.7%) | |
| Lobar pneumonia | 1/59 (1.7%) | |
| Oral candidiasis | 3/59 (5.1%) | |
| Sinusitis | 1/59 (1.7%) | |
| Upper respiratory tract infection | 1/59 (1.7%) | |
| Urinary tract infection | 2/59 (3.4%) | |
| Wound infection | 1/59 (1.7%) | |
| Injury, poisoning and procedural complications | ||
| Fall | 1/59 (1.7%) | |
| Gastrointestinal stoma complication | 1/59 (1.7%) | |
| Incision site complication | 1/59 (1.7%) | |
| Incision site erythema | 1/59 (1.7%) | |
| Incision site oedema | 1/59 (1.7%) | |
| Incision site pain | 2/59 (3.4%) | |
| Procedural hypertension | 1/59 (1.7%) | |
| Procedural pain | 36/59 (61%) | |
| Therapeutic agent toxicity | 1/59 (1.7%) | |
| Thermal burn | 1/59 (1.7%) | |
| Investigations | ||
| Blood creatinine increased | 1/59 (1.7%) | |
| Blood glucose increased | 2/59 (3.4%) | |
| Blood potassium increased | 1/59 (1.7%) | |
| Blood pressure increased | 1/59 (1.7%) | |
| Breath sounds abnormal | 1/59 (1.7%) | |
| Cardiac murmur | 1/59 (1.7%) | |
| Weight decreased | 1/59 (1.7%) | |
| Metabolism and nutrition disorders | ||
| Decreased appetite | 3/59 (5.1%) | |
| Dehydration | 4/59 (6.8%) | |
| Failure to thrive | 3/59 (5.1%) | |
| Hyperglycaemia | 17/59 (28.8%) | |
| Hyponatraemia | 2/59 (3.4%) | |
| Musculoskeletal and connective tissue disorders | ||
| Arthralgia | 1/59 (1.7%) | |
| Muscular weakness | 6/59 (10.2%) | |
| Musculoskeletal chest pain | 2/59 (3.4%) | |
| Soft tissue necrosis | 1/59 (1.7%) | |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Malignant neoplasm progression | 3/59 (5.1%) | |
| Metastases to bone | 1/59 (1.7%) | |
| Neoplasm recurrence | 1/59 (1.7%) | |
| Tumour associated fever | 1/59 (1.7%) | |
| Nervous system disorders | ||
| Amnesia | 1/59 (1.7%) | |
| Aphasia | 4/59 (6.8%) | |
| Brain stem infarction | 1/59 (1.7%) | |
| Clumsiness | 1/59 (1.7%) | |
| Convulsion | 6/59 (10.2%) | |
| Coordination abnormal | 1/59 (1.7%) | |
| Depressed level of consciousness | 1/59 (1.7%) | |
| Dizziness | 2/59 (3.4%) | |
| Headache | 13/59 (22%) | |
| Hemianopia homonymous | 1/59 (1.7%) | |
| Hemiparesis | 2/59 (3.4%) | |
| Hypoaesthesia | 2/59 (3.4%) | |
| Hypokinesia | 1/59 (1.7%) | |
| IVth nerve paralysis | 1/59 (1.7%) | |
| Intracranial hypotension | 1/59 (1.7%) | |
| Lethargy | 3/59 (5.1%) | |
| Paralysis | 1/59 (1.7%) | |
| Peroneal nerve palsy | 1/59 (1.7%) | |
| Pneumocephalus | 1/59 (1.7%) | |
| Subdural effusion | 2/59 (3.4%) | |
| Psychiatric disorders | ||
| Agitation | 2/59 (3.4%) | |
| Anxiety | 4/59 (6.8%) | |
| Confusional state | 3/59 (5.1%) | |
| Depression | 2/59 (3.4%) | |
| Insomnia | 3/59 (5.1%) | |
| Mental status changes | 1/59 (1.7%) | |
| Respiratory, thoracic and mediastinal disorders | ||
| Cough | 2/59 (3.4%) | |
| Dyspnoea | 6/59 (10.2%) | |
| Dyspnoea exertional | 2/59 (3.4%) | |
| Lung infiltration | 1/59 (1.7%) | |
| Pharyngolaryngeal pain | 1/59 (1.7%) | |
| Pneumonia aspiration | 1/59 (1.7%) | |
| Pneumothorax | 2/59 (3.4%) | |
| Productive cough | 1/59 (1.7%) | |
| Pulmonary embolism | 1/59 (1.7%) | |
| Rhinitis allergic | 1/59 (1.7%) | |
| Wheezing | 2/59 (3.4%) | |
| Skin and subcutaneous tissue disorders | ||
| Drug eruption | 4/59 (6.8%) | |
| Ecchymosis | 1/59 (1.7%) | |
| Erythema | 1/59 (1.7%) | |
| Hyperhidrosis | 1/59 (1.7%) | |
| Hypoaesthesia facial | 1/59 (1.7%) | |
| Periorbital oedema | 1/59 (1.7%) | |
| Petechiae | 1/59 (1.7%) | |
| Pruritus | 1/59 (1.7%) | |
| Rash | 2/59 (3.4%) | |
| Rash pruritic | 1/59 (1.7%) | |
| Vascular disorders | ||
| Deep vein thrombosis | 6/59 (10.2%) | |
| Hypertension | 4/59 (6.8%) | |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Eisai Medical Services |
|---|---|
| Organization | Eisai, Inc. |
| Phone | 1-888-422-4743 |
| esi_medinfo@eisai.com |
Responsible Party:
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00525590
Other Study ID Numbers:
- GLIA-001
First Posted:
Sep 6, 2007
Last Update Posted:
Mar 16, 2020
Last Verified:
Feb 1, 2020