Trial Outcomes & Findings for Radiation Therapy and Temozolomide Followed by Temozolomide and Poly ICLC in Treating Patients With Newly Diagnosed GBM (NCT NCT00262730)
NCT ID: NCT00262730
Last Updated: 2019-06-12
Results Overview
survival time is defined from time of histological diagnosis to death occurrence.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
97 participants
Primary outcome timeframe
30 months
Results posted on
2019-06-12
Participant Flow
outpatient clinic
Participant milestones
| Measure |
Treatment Arm - All Subjects
poly ICLC, temozolomide, radiation: radiation therapy
poly ICLC : 20 mcg/kg 3x each week (Maintenance cycles)
temozolomide : daily 75mg/m2 6wks concomitant therapy Wk 1 - days 1-5 150-200 mg/m2 maintenance cycles (adjuvant)
radiation therapy : RT: 60 Gy (6 weeks) concomitant therapy
|
|---|---|
|
Overall Study
STARTED
|
97
|
|
Overall Study
COMPLETED
|
97
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Radiation Therapy and Temozolomide Followed by Temozolomide and Poly ICLC in Treating Patients With Newly Diagnosed GBM
Baseline characteristics by cohort
| Measure |
Treatment Arm - All Subjects
n=97 Participants
poly ICLC, temozolomide, radiation: radiation therapy
poly ICLC : 20 mcg/kg 3x each week (Maintenance cycles)
temozolomide : daily 75mg/m2 6wks concomitant therapy Wk 1 - days 1-5 150-200 mg/m2 maintenance cycles (adjuvant)
radiation therapy : RT: 60 Gy (6 weeks) concomitant therapy
|
|---|---|
|
Age, Continuous
|
56.6 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=5 Participants
|
|
Karnofsky Performance Status
100
|
34 Units on a scale
n=5 Participants
|
|
Karnofsky Performance Status
90
|
45 Units on a scale
n=5 Participants
|
|
Karnofsky Performance Status
80
|
12 Units on a scale
n=5 Participants
|
|
Karnofsky Performance Status
70
|
3 Units on a scale
n=5 Participants
|
|
Karnofsky Performance Status
60
|
3 Units on a scale
n=5 Participants
|
|
Extent of surgery
Biopsy
|
18 Patient
n=5 Participants
|
|
Extent of surgery
Craniotomy
|
79 Patient
n=5 Participants
|
|
time from diagnosis to radiotherapy
|
4.4 weeks
n=5 Participants
|
|
Baseline Mini-Mental State Examiniation (MMSE) Score
30
|
56 Scores on a Scale
n=5 Participants
|
|
Baseline Mini-Mental State Examiniation (MMSE) Score
27-29
|
30 Scores on a Scale
n=5 Participants
|
|
Baseline Mini-Mental State Examiniation (MMSE) Score
Less than or equal 26
|
11 Scores on a Scale
n=5 Participants
|
|
Corticosteroid Therapy
Yes
|
70 Participant
n=5 Participants
|
|
Corticosteroid Therapy
No
|
26 Participant
n=5 Participants
|
|
Corticosteroid Therapy
Missing Data
|
1 Participant
n=5 Participants
|
|
Histologic Diagnosis
Glioblastoma
|
94 Patient
n=5 Participants
|
|
Histologic Diagnosis
Anaplastic Astrocytoma
|
1 Patient
n=5 Participants
|
|
Histologic Diagnosis
Other
|
2 Patient
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 monthsPopulation: all patients who were treated were analyzed (intent to treat)
survival time is defined from time of histological diagnosis to death occurrence.
Outcome measures
| Measure |
Treatment Arm - All Subjects
n=97 Participants
poly ICLC, temozolomide, radiation: radiation therapy
poly ICLC : 20 mcg/kg 3x each week (Maintenance cycles)
temozolomide : daily 75mg/m2 6wks concomitant therapy Wk 1 - days 1-5 150-200 mg/m2 maintenance cycles (adjuvant)
radiation therapy : RT: 60 Gy (6 weeks) concomitant therapy
|
|---|---|
|
Survival
|
17.2 months
Interval 15.4 to 19.3
|
Adverse Events
Treatment Arm All Subjects
Serious events: 20 serious events
Other events: 97 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment Arm All Subjects
n=97 participants at risk
poly ICLC, TMZ, RT: poly ICLC : 20 mcg/kg 3x each week (Maintenance cycles) TMX : daily 75mg/m2 6wks concomitant therapy Wk 1 - days 1-5 150-200 mg/m2 maintenance cycles (adjuvant) RT : RT: 60 Gy (6 weeks) concomitant therapy
AEs Grades 4 with Attributions of Possible, probably or definitely related to TMZ AND poly-ICLI
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
1.0%
1/97 • Number of events 1 • While on Treatment
|
|
General disorders
fatigue
|
3.1%
3/97 • Number of events 3 • While on Treatment
|
|
Musculoskeletal and connective tissue disorders
muscle weakness, generalized
|
1.0%
1/97 • Number of events 1 • While on Treatment
|
|
Nervous system disorders
nausea
|
1.0%
1/97 • Number of events 1 • While on Treatment
|
|
Gastrointestinal disorders
vomiting
|
1.0%
1/97 • Number of events 1 • While on Treatment
|
|
Skin and subcutaneous tissue disorders
rash
|
2.1%
2/97 • Number of events 2 • While on Treatment
|
|
Investigations
aspartate aminotransferase increased
|
1.0%
1/97 • Number of events 1 • While on Treatment
|
|
Blood and lymphatic system disorders
febrile neutropenia
|
2.1%
2/97 • Number of events 2 • While on Treatment
|
|
Blood and lymphatic system disorders
hemoglobin increased
|
2.1%
2/97 • Number of events 2 • While on Treatment
|
|
Infections and infestations
Lung infection
|
1.0%
1/97 • Number of events 1 • While on Treatment
|
|
Blood and lymphatic system disorders
leukopenia
|
16.5%
16/97 • Number of events 16 • While on Treatment
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
20.6%
20/97 • Number of events 20 • While on Treatment
|
|
Investigations
platelet count decreased
|
9.3%
9/97 • Number of events 9 • While on Treatment
|
Other adverse events
| Measure |
Treatment Arm All Subjects
n=97 participants at risk
poly ICLC, TMZ, RT: poly ICLC : 20 mcg/kg 3x each week (Maintenance cycles) TMX : daily 75mg/m2 6wks concomitant therapy Wk 1 - days 1-5 150-200 mg/m2 maintenance cycles (adjuvant) RT : RT: 60 Gy (6 weeks) concomitant therapy
AEs Grades 4 with Attributions of Possible, probably or definitely related to TMZ AND poly-ICLI
|
|---|---|
|
Investigations
Alkaline phosphatase increased
|
19.6%
19/97 • Number of events 66 • While on Treatment
|
|
Immune system disorders
allergic reaction
|
2.1%
2/97 • Number of events 2 • While on Treatment
|
|
Respiratory, thoracic and mediastinal disorders
allergic rhinitis
|
4.1%
4/97 • Number of events 4 • While on Treatment
|
|
Metabolism and nutrition disorders
anorexia
|
28.9%
28/97 • Number of events 35 • While on Treatment
|
|
Musculoskeletal and connective tissue disorders
arthritis
|
1.0%
1/97 • Number of events 1 • While on Treatment
|
|
Gastrointestinal disorders
ascites
|
1.0%
1/97 • Number of events 1 • While on Treatment
|
|
Nervous system disorders
ataxia
|
10.3%
10/97 • Number of events 12 • While on Treatment
|
|
Ear and labyrinth disorders
ear and labyrinth disorder
|
4.1%
4/97 • Number of events 4 • While on Treatment
|
|
Investigations
blood bicarbonate decreased
|
10.3%
10/97 • Number of events 13 • While on Treatment
|
|
Injury, poisoning and procedural complications
bruising
|
12.4%
12/97 • Number of events 17 • While on Treatment
|
|
Nervous system disorders
ischemia cerebrovascular
|
3.1%
3/97 • Number of events 3 • While on Treatment
|
|
Eye disorders
cataract
|
1.0%
1/97 • Number of events 1 • While on Treatment
|
|
Nervous system disorders
cognitive disturbance
|
2.1%
2/97 • Number of events 2 • While on Treatment
|
|
Gastrointestinal disorders
colitis
|
3.1%
3/97 • Number of events 3 • While on Treatment
|
|
Nervous system disorders
confusion
|
18.6%
18/97 • Number of events 26 • While on Treatment
|
|
Gastrointestinal disorders
constipation
|
39.2%
38/97 • Number of events 52 • While on Treatment
|
|
General disorders
cough
|
18.6%
18/97 • Number of events 22 • While on Treatment
|
|
Investigations
creatinine increased
|
3.1%
3/97 • Number of events 3 • While on Treatment
|
|
Endocrine disorders
cushingoid
|
8.2%
8/97 • Number of events 8 • While on Treatment
|
|
Renal and urinary disorders
cystitis
|
1.0%
1/97 • Number of events 1 • While on Treatment
|
|
Metabolism and nutrition disorders
dehydration
|
3.1%
3/97 • Number of events 3 • While on Treatment
|
|
Gastrointestinal disorders
periodontal disease
|
1.0%
1/97 • Number of events 1 • While on Treatment
|
|
Skin and subcutaneous tissue disorders
dermatology/skin
|
5.2%
5/97 • Number of events 5 • While on Treatment
|
|
Gastrointestinal disorders
diarrhea
|
13.4%
13/97 • Number of events 19 • While on Treatment
|
|
Gastrointestinal disorders
distension/bloating
|
1.0%
1/97 • Number of events 1 • While on Treatment
|
|
Nervous system disorders
dizziness
|
24.7%
24/97 • Number of events 28 • While on Treatment
|
|
Eye disorders
dry eye
|
3.1%
3/97 • Number of events 3 • While on Treatment
|
|
Gastrointestinal disorders
dry mouth
|
2.1%
2/97 • Number of events 2 • While on Treatment
|
|
Skin and subcutaneous tissue disorders
dry skin
|
4.1%
4/97 • Number of events 5 • While on Treatment
|
|
Gastrointestinal disorders
dysphagia
|
3.1%
3/97 • Number of events 3 • While on Treatment
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
15.5%
15/97 • Number of events 18 • While on Treatment
|
|
General disorders
edema
|
19.6%
19/97 • Number of events 28 • While on Treatment
|
|
Nervous system disorders
encephalopathy
|
1.0%
1/97 • Number of events 1 • While on Treatment
|
|
Endocrine disorders
endocrine
|
1.0%
1/97 • Number of events 1 • While on Treatment
|
|
Musculoskeletal and connective tissue disorders
extremity - lower (gait/walking)
|
1.0%
1/97 • Number of events 1 • While on Treatment
|
|
General disorders
fatigue
|
72.2%
70/97 • Number of events 112 • While on Treatment
|
|
Blood and lymphatic system disorders
febrile neutropenia
|
3.1%
3/97 • Number of events 3 • While on Treatment
|
|
General disorders
fever
|
9.3%
9/97 • Number of events 13 • While on Treatment
|
|
General disorders
flu like symptoms
|
3.1%
3/97 • Number of events 4 • While on Treatment
|
|
Vascular disorders
flushing
|
1.0%
1/97 • Number of events 1 • While on Treatment
|
|
Injury, poisoning and procedural complications
fracture
|
1.0%
1/97 • Number of events 1 • While on Treatment
|
|
Gastrointestinal disorders
gastritis
|
3.1%
3/97 • Number of events 3 • While on Treatment
|
|
Gastrointestinal disorders
gastrointestinal
|
4.1%
4/97 • Number of events 8 • While on Treatment
|
|
Metabolism and nutrition disorders
hyperglycemia
|
67.0%
65/97 • Number of events 246 • While on Treatment
|
|
Blood and lymphatic system disorders
anemia
|
73.2%
71/97 • Number of events 760 • While on Treatment
|
|
Skin and subcutaneous tissue disorders
alopecia
|
40.2%
39/97 • Number of events 39 • While on Treatment
|
|
Ear and labyrinth disorders
hearing
|
4.1%
4/97 • Number of events 4 • While on Treatment
|
|
Gastrointestinal disorders
dyspepsia
|
12.4%
12/97 • Number of events 12 • While on Treatment
|
|
Blood and lymphatic system disorders
hemoglobin increase
|
2.1%
2/97 • Number of events 2 • While on Treatment
|
|
Nervous system disorders
hemorrhage
|
1.0%
1/97 • Number of events 1 • While on Treatment
|
|
Infections and infestations
esophageal hemorrhage
|
1.0%
1/97 • Number of events 1 • While on Treatment
|
|
Gastrointestinal disorders
rectal hemorrhage
|
1.0%
1/97 • Number of events 1 • While on Treatment
|
|
Renal and urinary disorders
hemorrhage
|
1.0%
1/97 • Number of events 1 • While on Treatment
|
|
Respiratory, thoracic and mediastinal disorders
hemorrhage
|
2.1%
2/97 • Number of events 2 • While on Treatment
|
|
Respiratory, thoracic and mediastinal disorders
hiccups
|
1.0%
1/97 • Number of events 1 • While on Treatment
|
|
Vascular disorders
hot flashes
|
2.1%
2/97 • Number of events 2 • While on Treatment
|
|
Nervous system disorders
hydrocephalus
|
4.1%
4/97 • Number of events 4 • While on Treatment
|
|
Metabolism and nutrition disorders
hypercalcemia
|
6.2%
6/97 • Number of events 9 • While on Treatment
|
|
Metabolism and nutrition disorders
hyperkalemia
|
1.0%
1/97 • Number of events 1 • While on Treatment
|
|
Metabolism and nutrition disorders
hypermagnesemia
|
18.6%
18/97 • Number of events 27 • While on Treatment
|
|
Metabolism and nutrition disorders
hypernatremia
|
12.4%
12/97 • Number of events 20 • While on Treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
hyperpigmentation
|
1.0%
1/97 • Number of events 1 • While on Treatment
|
|
Vascular disorders
hypertension
|
2.1%
2/97 • Number of events 2 • While on Treatment
|
|
Metabolism and nutrition disorders
hypocalcemia
|
18.6%
18/97 • Number of events 33 • While on Treatment
|
|
Metabolism and nutrition disorders
hypoglycemia
|
20.6%
20/97 • Number of events 41 • While on Treatment
|
|
Metabolism and nutrition disorders
hypokalemia
|
3.1%
3/97 • Number of events 4 • While on Treatment
|
|
Metabolism and nutrition disorders
hypomagnesemia
|
6.2%
6/97 • Number of events 9 • While on Treatment
|
|
Metabolism and nutrition disorders
hyponatremia
|
2.1%
2/97 • Number of events 2 • While on Treatment
|
|
Vascular disorders
hypotension
|
7.2%
7/97 • Number of events 9 • While on Treatment
|
|
Respiratory, thoracic and mediastinal disorders
hypoxia
|
1.0%
1/97 • Number of events 1 • While on Treatment
|
|
Hepatobiliary disorders
International Normalized Ratio of prothrombin time
|
2.1%
2/97 • Number of events 2 • While on Treatment
|
|
Renal and urinary disorders
urinary incontinence
|
4.1%
4/97 • Number of events 5 • While on Treatment
|
|
Infections and infestations
infection
|
43.3%
42/97 • Number of events 45 • While on Treatment
|
|
Psychiatric disorders
insomnia
|
20.6%
20/97 • Number of events 26 • While on Treatment
|
|
Injury, poisoning and procedural complications
injury
|
1.0%
1/97 • Number of events 1 • While on Treatment
|
|
Musculoskeletal and connective tissue disorders
joint function
|
2.1%
2/97 • Number of events 2 • While on Treatment
|
|
Blood and lymphatic system disorders
leukocytes
|
2.1%
2/97 • Number of events 2 • While on Treatment
|
|
Psychiatric disorders
libido decreased
|
2.1%
2/97 • Number of events 2 • While on Treatment
|
|
Musculoskeletal and connective tissue disorders
lumbar spine range of motion decreased
|
1.0%
1/97 • Number of events 1 • While on Treatment
|
|
Nervous system disorders
memory impairment
|
27.8%
27/97 • Number of events 32 • While on Treatment
|
|
Psychiatric disorders
mood alteration
|
37.1%
36/97 • Number of events 39 • While on Treatment
|
|
Gastrointestinal disorders
mucositis oral
|
11.3%
11/97 • Number of events 12 • While on Treatment
|
|
Musculoskeletal and connective tissue disorders
muscle weakness, generalized or specific area
|
34.0%
33/97 • Number of events 43 • While on Treatment
|
|
Musculoskeletal and connective tissue disorders
soft tissue
|
5.2%
5/97 • Number of events 7 • While on Treatment
|
|
Skin and subcutaneous tissue disorders
nail changes
|
1.0%
1/97 • Number of events 1 • While on Treatment
|
|
Respiratory, thoracic and mediastinal disorders
paranasal sinus reaction
|
2.1%
2/97 • Number of events 2 • While on Treatment
|
|
Gastrointestinal disorders
nausea
|
42.3%
41/97 • Number of events 64 • While on Treatment
|
|
Nervous system disorders
neurological disorder
|
8.2%
8/97 • Number of events 8 • While on Treatment
|
|
Nervous system disorders
neuropathy
|
59.8%
58/97 • Number of events 80 • While on Treatment
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
3.1%
3/97 • Number of events 3 • While on Treatment
|
|
Renal and urinary disorders
obstruction
|
2.1%
2/97 • Number of events 2 • While on Treatment
|
|
Eye disorders
ocular/vision disorder
|
2.1%
2/97 • Number of events 2 • While on Treatment
|
|
Eye disorders
diplopia (double vision)
|
3.1%
3/97 • Number of events 4 • While on Treatment
|
|
Blood and lymphatic system disorders
lymphopenia
|
1.0%
1/97 • Number of events 1 • While on Treatment
|
|
Ear and labyrinth disorders
otitis
|
2.1%
2/97 • Number of events 2 • While on Treatment
|
|
Blood and lymphatic system disorders
PLTS
|
60.8%
59/97 • Number of events 468 • While on Treatment
|
|
Blood and lymphatic system disorders
PO4
|
19.6%
19/97 • Number of events 31 • While on Treatment
|
|
Investigations
PTT
|
4.1%
4/97 • Number of events 10 • While on Treatment
|
|
Gastrointestinal disorders
pain - abdomen
|
2.1%
2/97 • Number of events 2 • While on Treatment
|
|
Musculoskeletal and connective tissue disorders
pain - back
|
8.2%
8/97 • Number of events 10 • While on Treatment
|
|
Musculoskeletal and connective tissue disorders
pain - bone
|
1.0%
1/97 • Number of events 1 • While on Treatment
|
|
Reproductive system and breast disorders
pain - breast
|
1.0%
1/97 • Number of events 1 • While on Treatment
|
|
Cardiac disorders
pain - cardiac/heart/chest
|
3.1%
3/97 • Number of events 3 • While on Treatment
|
|
General disorders
pain - chest/thorax
|
4.1%
4/97 • Number of events 6 • While on Treatment
|
|
Gastrointestinal disorders
pain - dental/teeth/peridontal
|
1.0%
1/97 • Number of events 1 • While on Treatment
|
|
Ear and labyrinth disorders
pain - external ear
|
1.0%
1/97 • Number of events 1 • While on Treatment
|
|
Musculoskeletal and connective tissue disorders
pain - extremity
|
14.4%
14/97 • Number of events 16 • While on Treatment
|
|
Eye disorders
pain - eye
|
2.1%
2/97 • Number of events 2 • While on Treatment
|
|
Nervous system disorders
headache
|
52.6%
51/97 • Number of events 80 • While on Treatment
|
|
Musculoskeletal and connective tissue disorders
pain - joint
|
16.5%
16/97 • Number of events 21 • While on Treatment
|
|
Ear and labyrinth disorders
pain - middle ear
|
3.1%
3/97 • Number of events 3 • While on Treatment
|
|
Musculoskeletal and connective tissue disorders
pain - muscle
|
17.5%
17/97 • Number of events 23 • While on Treatment
|
|
Musculoskeletal and connective tissue disorders
pain - neck
|
6.2%
6/97 • Number of events 6 • While on Treatment
|
|
Gastrointestinal disorders
pain - oral
|
1.0%
1/97 • Number of events 1 • While on Treatment
|
|
General disorders
pain - other
|
4.1%
4/97 • Number of events 4 • While on Treatment
|
|
Skin and subcutaneous tissue disorders
pain - scalp
|
3.1%
3/97 • Number of events 3 • While on Treatment
|
|
Skin and subcutaneous tissue disorders
pain - skin
|
3.1%
3/97 • Number of events 3 • While on Treatment
|
|
Gastrointestinal disorders
pain - stomach
|
2.1%
2/97 • Number of events 2 • While on Treatment
|
|
Cardiac disorders
palpitations
|
4.1%
4/97 • Number of events 4 • While on Treatment
|
|
Psychiatric disorders
personality/behavioral disorder
|
1.0%
1/97 • Number of events 1 • While on Treatment
|
|
Eye disorders
photosensitivity
|
1.0%
1/97 • Number of events 1 • While on Treatment
|
|
Blood and lymphatic system disorders
platelets
|
2.1%
2/97 • Number of events 3 • While on Treatment
|
|
Respiratory, thoracic and mediastinal disorders
pneumothorax
|
1.0%
1/97 • Number of events 1 • While on Treatment
|
|
Skin and subcutaneous tissue disorders
pruritus/itching
|
9.3%
9/97 • Number of events 11 • While on Treatment
|
|
Psychiatric disorders
psychosis
|
3.1%
3/97 • Number of events 3 • While on Treatment
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary/upper respiratory
|
2.1%
2/97 • Number of events 2 • While on Treatment
|
|
Nervous system disorders
pyramidal tract dysfunction
|
1.0%
1/97 • Number of events 1 • While on Treatment
|
|
Skin and subcutaneous tissue disorders
purpura
|
2.1%
2/97 • Number of events 3 • While on Treatment
|
|
Skin and subcutaneous tissue disorders
rash - acneiform
|
4.1%
4/97 • Number of events 4 • While on Treatment
|
|
Injury, poisoning and procedural complications
rash
|
20.6%
20/97 • Number of events 20 • While on Treatment
|
|
Skin and subcutaneous tissue disorders
rash - desquamation
|
20.6%
20/97 • Number of events 27 • While on Treatment
|
|
General disorders
rigors/chills
|
5.2%
5/97 • Number of events 7 • While on Treatment
|
|
Investigations
SGOT/AST
|
18.6%
18/97 • Number of events 37 • While on Treatment
|
|
Investigations
SGPT/ALT
|
35.1%
34/97 • Number of events 131 • While on Treatment
|
|
Nervous system disorders
seizure
|
35.1%
34/97 • Number of events 68 • While on Treatment
|
|
Skin and subcutaneous tissue disorders
skin breakdown/decubitus ulcer
|
1.0%
1/97 • Number of events 1 • While on Treatment
|
|
Nervous system disorders
somnolence
|
4.1%
4/97 • Number of events 4 • While on Treatment
|
|
Nervous system disorders
speech impairment
|
22.7%
22/97 • Number of events 34 • While on Treatment
|
|
Cardiac disorders
supraventricular and nodal arrhythmia
|
1.0%
1/97 • Number of events 1 • While on Treatment
|
|
Skin and subcutaneous tissue disorders
sweating (diaphoresis)
|
3.1%
3/97 • Number of events 3 • While on Treatment
|
|
Nervous system disorders
syncope
|
3.1%
3/97 • Number of events 3 • While on Treatment
|
|
General disorders
syndromes - other
|
1.0%
1/97 • Number of events 1 • While on Treatment
|
|
Gastrointestinal disorders
taste alteration
|
11.3%
11/97 • Number of events 12 • While on Treatment
|
|
Nervous system disorders
thrombosis/thrombus/embolism
|
12.4%
12/97 • Number of events 14 • While on Treatment
|
|
Ear and labyrinth disorders
tinnitus
|
7.2%
7/97 • Number of events 9 • While on Treatment
|
|
Investigations
total bilirubin
|
3.1%
3/97 • Number of events 5 • While on Treatment
|
|
Nervous system disorders
tremor
|
6.2%
6/97 • Number of events 6 • While on Treatment
|
|
Gastrointestinal disorders
ulceration
|
1.0%
1/97 • Number of events 2 • While on Treatment
|
|
Metabolism and nutrition disorders
uric acid
|
6.2%
6/97 • Number of events 13 • While on Treatment
|
|
Renal and urinary disorders
urinary frequency
|
3.1%
3/97 • Number of events 3 • While on Treatment
|
|
Renal and urinary disorders
urinary retention
|
3.1%
3/97 • Number of events 3 • While on Treatment
|
|
Skin and subcutaneous tissue disorders
urticaria
|
1.0%
1/97 • Number of events 1 • While on Treatment
|
|
Reproductive system and breast disorders
vaginal discharge
|
1.0%
1/97 • Number of events 1 • While on Treatment
|
|
Vascular disorders
vascular - other
|
2.1%
2/97 • Number of events 3 • While on Treatment
|
|
Eye disorders
vision - blurred
|
16.5%
16/97 • Number of events 20 • While on Treatment
|
|
Eye disorders
vision - flashing lights/floaters
|
4.1%
4/97 • Number of events 4 • While on Treatment
|
|
Respiratory, thoracic and mediastinal disorders
voice changes
|
2.1%
2/97 • Number of events 2 • While on Treatment
|
|
Investigations
white blood cells
|
66.0%
64/97 • Number of events 793 • While on Treatment
|
|
Eye disorders
watery eye
|
1.0%
1/97 • Number of events 1 • While on Treatment
|
|
Metabolism and nutrition disorders
weight gain
|
2.1%
2/97 • Number of events 2 • While on Treatment
|
|
Metabolism and nutrition disorders
weight loss
|
10.3%
10/97 • Number of events 10 • While on Treatment
|
Additional Information
Director of Adult Brain Tumor Consortium
Adult Brain Tumor Consortium Central Office- Johns Hopkins
Phone: 410-955-3657
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place