Trial Outcomes & Findings for Ramucirumab or Anti-PDGFR Alpha Monoclonal Antibody IMC-3G3 in Treating Patients With Recurrent Glioblastoma Multiforme (NCT NCT00895180)
NCT ID: NCT00895180
Last Updated: 2017-12-27
Results Overview
PFS was defined as the start of treatment to the earliest date of tumor progression or death from any cause based on the modified Response Assessment in Neuro-Oncology Group through the American Society of Clinical Oncology (RANO) criteria. Progression is defined by any of the following: ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions; any new lesion; or clinical deterioration. RANO is a standardized response criteria using bi-dimensional measurements of the largest contrast-enhancing area (Macdonald, 1990).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
80 participants
Primary outcome timeframe
Start of treatment to PD or Death Up To 6 Months
Results posted on
2017-12-27
Participant Flow
The completers include those participants with progressive disease (PD) or those who died.
Participant milestones
| Measure |
Group 1 Ramucirumab
Participants receive ramucirumab intravenously (IV) over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Group 2 Olaratumab
Participants receive olaratumab IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
40
|
40
|
|
Overall Study
COMPLETED
|
40
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ramucirumab or Anti-PDGFR Alpha Monoclonal Antibody IMC-3G3 in Treating Patients With Recurrent Glioblastoma Multiforme
Baseline characteristics by cohort
| Measure |
Group 1 Ramucirumab
n=40 Participants
Participants receive ramucirumab IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Group 2 Olaratumab
n=40 Participants
Participants receive olaratumab IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.4 years
STANDARD_DEVIATION 12.29 • n=5 Participants
|
51.6 years
STANDARD_DEVIATION 11.81 • n=7 Participants
|
51.5 years
STANDARD_DEVIATION 11.98 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
40 participants
n=7 Participants
|
80 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Start of treatment to PD or Death Up To 6 MonthsPopulation: All enrolled participants who received at least one dose of study drug.
PFS was defined as the start of treatment to the earliest date of tumor progression or death from any cause based on the modified Response Assessment in Neuro-Oncology Group through the American Society of Clinical Oncology (RANO) criteria. Progression is defined by any of the following: ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions; any new lesion; or clinical deterioration. RANO is a standardized response criteria using bi-dimensional measurements of the largest contrast-enhancing area (Macdonald, 1990).
Outcome measures
| Measure |
Group 1 Ramucirumab
n=40 Participants
Participants receive ramucirumab intravenously (IV) over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Group 2 Olaratumab
n=40 Participants
Participants receive olaratumab IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Percentage of Participants Who Achieved Progression-Free Survival Rate at 6 Months (PFS-6)
|
12.5 percentage of participants
|
7.5 percentage of participants
|
SECONDARY outcome
Timeframe: Start of Treatment to End of Study (Up to 13 Months)Population: All enrolled participants who received at least one dose of study drug.
The number of participants who experienced serious adverse events (SAEs) that were considered to be related to ramucirumab or olaratumab. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.
Outcome measures
| Measure |
Group 1 Ramucirumab
n=40 Participants
Participants receive ramucirumab intravenously (IV) over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Group 2 Olaratumab
n=40 Participants
Participants receive olaratumab IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events as Assessed by NCI CTCAE v4.0 (National Cancer Institute-Common Terminology Criteria for Adverse Events)
SAE
|
13 participants
|
14 participants
|
|
Number of Participants With Treatment Emergent Adverse Events as Assessed by NCI CTCAE v4.0 (National Cancer Institute-Common Terminology Criteria for Adverse Events)
Other adverse events (AEs)
|
38 participants
|
39 participants
|
SECONDARY outcome
Timeframe: Start of Treatment to PD Up To 20 MonthsPopulation: All enrolled participants who received at least one dose of study drug.
The pts achievement of both measurement and confirmation criteria for a status of CR, PR or MR based on the modified RANO criteria.CR requires all of the following:complete disappearance of all enhancing measurable and non-measurable disease sustained for at least 4 weeks (wks);no new lesions;no corticosteroids;and stable or improved clinically.PR requires all of the following:≥ 50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for at least 4 wks;no new lesions;stable or reduced corticosteroid dose;and stable or improved clinically.MR requires ≥ 25% reduction in sum of products of the perpendicular diameters of all measureable enhancing lesions sustained for at least 4 wks and no new lesions or progression of non-measurable lesions. PD is defined by any of these: ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions;any new lesion;or clinical deterioration.
Outcome measures
| Measure |
Group 1 Ramucirumab
n=40 Participants
Participants receive ramucirumab intravenously (IV) over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Group 2 Olaratumab
n=40 Participants
Participants receive olaratumab IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Percentage of Participants (Pts) With Complete Response (CR), Partial Response (PR) and Minor Response (MR) (Objective Response Rate [ORR])
|
0 percentage of participants
|
2.5 percentage of participants
|
SECONDARY outcome
Timeframe: Start of Treatment to Death Up To 27 MonthsPopulation: All enrolled participants who received at least one dose of study drug. Participants censored in ramucirumab = 4 and olaratumab = 4.
OS is the time from the start of treatment to the date of death. Participants who had not expired by the data analysis cutoff date were censored at their last date known to be alive.
Outcome measures
| Measure |
Group 1 Ramucirumab
n=40 Participants
Participants receive ramucirumab intravenously (IV) over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Group 2 Olaratumab
n=40 Participants
Participants receive olaratumab IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Median Overall Survival (OS)
|
49.5 Weeks
Interval 31.1 to 58.7
|
34.3 Weeks
Interval 24.1 to 46.9
|
SECONDARY outcome
Timeframe: Cycle 7, Day 1: Prior to Infusion,1 hour (hr) Post InfusionPopulation: All enrolled participants who received at least one dose of ramucirumab and had evaluable PK data.
Outcome measures
| Measure |
Group 1 Ramucirumab
n=6 Participants
Participants receive ramucirumab intravenously (IV) over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Group 2 Olaratumab
Participants receive olaratumab IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Pharmacokinetics (PK): Concentration Maximum (Cmax) and Concentration Minimum (Cmin) of Ramucirumab
Cmin (n=5)
|
85.0 microgram/milliliter (μg/mL)
Geometric Coefficient of Variation 25
|
—
|
|
Pharmacokinetics (PK): Concentration Maximum (Cmax) and Concentration Minimum (Cmin) of Ramucirumab
Cmax (n=6)
|
396 microgram/milliliter (μg/mL)
Geometric Coefficient of Variation 30
|
—
|
SECONDARY outcome
Timeframe: Cycle 3, Day 1: Prior to Infusion, 1 hr Post InfusionPopulation: All enrolled participants who received at least one dose of Olaratumab and had evaluable PK data.
Outcome measures
| Measure |
Group 1 Ramucirumab
n=5 Participants
Participants receive ramucirumab intravenously (IV) over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Group 2 Olaratumab
Participants receive olaratumab IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
PK: Cmax and Cmin of Olaratumab
Cmin (n=5)
|
145 μg/mL
Geometric Coefficient of Variation 22
|
—
|
|
PK: Cmax and Cmin of Olaratumab
Cmax (n=5)
|
515 μg/mL
Geometric Coefficient of Variation 23
|
—
|
SECONDARY outcome
Timeframe: Cycle 7, Day 1: Prior to Infusion, 1 hr Post InfusionPopulation: Zero participants were analyzed for pharmacodynamic profile as the plasma collection procedure in this study was not fit for this purpose.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Start of Treatment to 30-day Post Infusion Follow Up (Up to 6 Months)Population: All enrolled participant who had any amount of olaratumab and evaluable anti-olaratumab antibody data.
Percentage of Participants with Treatment Emergent (TE) anti-olaratumab antibodies were participants with a 4-fold increase (2 dilutions) increase over a positive baseline antibody titer or for a negative baseline titer, a participant with an increase from the baseline to a level of 1:20.
Outcome measures
| Measure |
Group 1 Ramucirumab
n=26 Participants
Participants receive ramucirumab intravenously (IV) over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Group 2 Olaratumab
Participants receive olaratumab IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Percentage of Participants With Anti-Olaratumab Antibodies (ADA)
|
0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Start of Treatment to 30-day Post Infusion Follow Up (Up to 6 Months)Population: All enrolled participants who had any amount of ramucirumab and evaluable anti-ramucirumab antibodies.
Percentage of Participants with Treatment Emergent (TE) anti-ramucirumab antibodies were participants with a 4-fold increase (2 dilutions) increase over a positive baseline antibody titer or for a negative baseline titer, a participant with an increase from the baseline to a level of 1:20.
Outcome measures
| Measure |
Group 1 Ramucirumab
n=32 Participants
Participants receive ramucirumab intravenously (IV) over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Group 2 Olaratumab
Participants receive olaratumab IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Percentage of Participants With Anti-Ramucirumab Antibodies (ADA)
|
3.1 percentage of participants
|
—
|
Adverse Events
Group 1 Ramucirumab
Serious events: 13 serious events
Other events: 38 other events
Deaths: 0 deaths
Group 2 Olaratumab
Serious events: 14 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1 Ramucirumab
n=40 participants at risk
Participants receive ramucirumab IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Group 2 Olaratumab
n=40 participants at risk
Participants receive olaratumab IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
2.5%
1/40 • Number of events 1
|
0.00%
0/40
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.5%
1/40 • Number of events 1
|
0.00%
0/40
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/40
|
2.5%
1/40 • Number of events 1
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
2.5%
1/40 • Number of events 2
|
0.00%
0/40
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/40
|
2.5%
1/40 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/40
|
2.5%
1/40 • Number of events 1
|
|
General disorders
Fatigue
|
2.5%
1/40 • Number of events 1
|
2.5%
1/40 • Number of events 1
|
|
General disorders
Gait disturbance
|
2.5%
1/40 • Number of events 1
|
0.00%
0/40
|
|
General disorders
Pyrexia
|
2.5%
1/40 • Number of events 1
|
0.00%
0/40
|
|
Infections and infestations
Bacteremia
|
0.00%
0/40
|
2.5%
1/40 • Number of events 1
|
|
Infections and infestations
Lung infection
|
0.00%
0/40
|
2.5%
1/40 • Number of events 1
|
|
Infections and infestations
Shunt infection
|
0.00%
0/40
|
2.5%
1/40 • Number of events 3
|
|
Infections and infestations
Urinary tract infection
|
2.5%
1/40 • Number of events 1
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Fall
|
2.5%
1/40 • Number of events 1
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Incorrect storage of drug
|
5.0%
2/40 • Number of events 2
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Medication error
|
5.0%
2/40 • Number of events 2
|
0.00%
0/40
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/40
|
7.5%
3/40 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.5%
1/40 • Number of events 2
|
0.00%
0/40
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/40
|
2.5%
1/40 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.5%
1/40 • Number of events 2
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
7.5%
3/40 • Number of events 3
|
2.5%
1/40 • Number of events 1
|
|
Nervous system disorders
Brain edema
|
2.5%
1/40 • Number of events 1
|
0.00%
0/40
|
|
Nervous system disorders
Cerebral hematoma
|
2.5%
1/40 • Number of events 1
|
0.00%
0/40
|
|
Nervous system disorders
Cognitive disorder
|
2.5%
1/40 • Number of events 1
|
0.00%
0/40
|
|
Nervous system disorders
Convulsion
|
7.5%
3/40 • Number of events 3
|
2.5%
1/40 • Number of events 1
|
|
Nervous system disorders
Depressed level of consciousness
|
2.5%
1/40 • Number of events 1
|
0.00%
0/40
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/40
|
2.5%
1/40 • Number of events 1
|
|
Nervous system disorders
Hemorrhage intracranial
|
5.0%
2/40 • Number of events 2
|
2.5%
1/40 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.00%
0/40
|
2.5%
1/40 • Number of events 1
|
|
Nervous system disorders
Hydrocephalus
|
2.5%
1/40 • Number of events 1
|
0.00%
0/40
|
|
Nervous system disorders
Vasogenic cerebral edema
|
0.00%
0/40
|
2.5%
1/40 • Number of events 1
|
|
Psychiatric disorders
Depression
|
0.00%
0/40
|
2.5%
1/40 • Number of events 1
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/40
|
2.5%
1/40 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/40
|
2.5%
1/40 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
5.0%
2/40 • Number of events 2
|
2.5%
1/40 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
2.5%
1/40 • Number of events 1
|
0.00%
0/40
|
|
Vascular disorders
Deep vein thrombosis
|
7.5%
3/40 • Number of events 3
|
5.0%
2/40 • Number of events 2
|
|
Vascular disorders
Hypertension
|
0.00%
0/40
|
2.5%
1/40 • Number of events 1
|
Other adverse events
| Measure |
Group 1 Ramucirumab
n=40 participants at risk
Participants receive ramucirumab IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Group 2 Olaratumab
n=40 participants at risk
Participants receive olaratumab IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.0%
2/40 • Number of events 2
|
10.0%
4/40 • Number of events 4
|
|
Endocrine disorders
Cushingoid
|
10.0%
4/40 • Number of events 4
|
5.0%
2/40 • Number of events 2
|
|
Eye disorders
Vision blurred
|
7.5%
3/40 • Number of events 3
|
5.0%
2/40 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
7.5%
3/40 • Number of events 3
|
15.0%
6/40 • Number of events 6
|
|
Gastrointestinal disorders
Diarrhea
|
12.5%
5/40 • Number of events 7
|
25.0%
10/40 • Number of events 17
|
|
Gastrointestinal disorders
Faecal incontinence
|
7.5%
3/40 • Number of events 3
|
0.00%
0/40
|
|
Gastrointestinal disorders
Nausea
|
20.0%
8/40 • Number of events 9
|
30.0%
12/40 • Number of events 20
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
5/40 • Number of events 5
|
17.5%
7/40 • Number of events 9
|
|
General disorders
Asthenia
|
7.5%
3/40 • Number of events 3
|
2.5%
1/40 • Number of events 1
|
|
General disorders
Chills
|
5.0%
2/40 • Number of events 2
|
7.5%
3/40 • Number of events 3
|
|
General disorders
Fatigue
|
47.5%
19/40 • Number of events 25
|
45.0%
18/40 • Number of events 24
|
|
General disorders
Gait disturbance
|
15.0%
6/40 • Number of events 10
|
15.0%
6/40 • Number of events 7
|
|
General disorders
Non-cardiac chest pain
|
5.0%
2/40 • Number of events 2
|
7.5%
3/40 • Number of events 3
|
|
General disorders
Edema peripheral
|
15.0%
6/40 • Number of events 8
|
12.5%
5/40 • Number of events 6
|
|
Infections and infestations
Upper respiratory tract infection
|
7.5%
3/40 • Number of events 4
|
7.5%
3/40 • Number of events 3
|
|
Infections and infestations
Urinary tract infection
|
7.5%
3/40 • Number of events 5
|
5.0%
2/40 • Number of events 2
|
|
Infections and infestations
Vaginal infection
|
8.3%
1/12 • Number of events 2
|
0.00%
0/16
|
|
Injury, poisoning and procedural complications
Contusion
|
15.0%
6/40 • Number of events 7
|
5.0%
2/40 • Number of events 2
|
|
Injury, poisoning and procedural complications
Fall
|
15.0%
6/40 • Number of events 9
|
10.0%
4/40 • Number of events 4
|
|
Investigations
Weight increased
|
5.0%
2/40 • Number of events 2
|
10.0%
4/40 • Number of events 5
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.5%
3/40 • Number of events 3
|
5.0%
2/40 • Number of events 2
|
|
Metabolism and nutrition disorders
Dehydration
|
5.0%
2/40 • Number of events 3
|
7.5%
3/40 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.5%
3/40 • Number of events 7
|
5.0%
2/40 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
2.5%
1/40 • Number of events 1
|
7.5%
3/40 • Number of events 16
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.0%
2/40 • Number of events 2
|
17.5%
7/40 • Number of events 10
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
4/40 • Number of events 4
|
15.0%
6/40 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.0%
2/40 • Number of events 2
|
7.5%
3/40 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
15.0%
6/40 • Number of events 6
|
15.0%
6/40 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.5%
3/40 • Number of events 3
|
5.0%
2/40 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.0%
2/40 • Number of events 2
|
12.5%
5/40 • Number of events 5
|
|
Nervous system disorders
Aphasia
|
15.0%
6/40 • Number of events 9
|
12.5%
5/40 • Number of events 6
|
|
Nervous system disorders
Balance disorder
|
7.5%
3/40 • Number of events 3
|
5.0%
2/40 • Number of events 2
|
|
Nervous system disorders
Cognitive disorder
|
12.5%
5/40 • Number of events 7
|
2.5%
1/40 • Number of events 1
|
|
Nervous system disorders
Convulsion
|
12.5%
5/40 • Number of events 6
|
10.0%
4/40 • Number of events 9
|
|
Nervous system disorders
Disturbance in attention
|
7.5%
3/40 • Number of events 4
|
0.00%
0/40
|
|
Nervous system disorders
Dizziness
|
12.5%
5/40 • Number of events 5
|
20.0%
8/40 • Number of events 9
|
|
Nervous system disorders
Dysarthria
|
10.0%
4/40 • Number of events 4
|
2.5%
1/40 • Number of events 1
|
|
Nervous system disorders
Headache
|
40.0%
16/40 • Number of events 21
|
30.0%
12/40 • Number of events 20
|
|
Nervous system disorders
Hemiparesis
|
2.5%
1/40 • Number of events 1
|
10.0%
4/40 • Number of events 7
|
|
Nervous system disorders
Hypoesthesia
|
7.5%
3/40 • Number of events 4
|
2.5%
1/40 • Number of events 1
|
|
Nervous system disorders
Memory impairment
|
7.5%
3/40 • Number of events 3
|
10.0%
4/40 • Number of events 4
|
|
Nervous system disorders
Tremor
|
10.0%
4/40 • Number of events 5
|
7.5%
3/40 • Number of events 3
|
|
Psychiatric disorders
Anxiety
|
7.5%
3/40 • Number of events 3
|
5.0%
2/40 • Number of events 2
|
|
Psychiatric disorders
Confusional state
|
15.0%
6/40 • Number of events 7
|
7.5%
3/40 • Number of events 3
|
|
Psychiatric disorders
Insomnia
|
5.0%
2/40 • Number of events 2
|
20.0%
8/40 • Number of events 8
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/40
|
12.5%
5/40 • Number of events 10
|
|
Renal and urinary disorders
Urinary incontinence
|
2.5%
1/40 • Number of events 2
|
7.5%
3/40 • Number of events 3
|
|
Reproductive system and breast disorders
Amenorrhea
|
0.00%
0/12
|
6.2%
1/16 • Number of events 1
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
8.3%
1/12 • Number of events 1
|
0.00%
0/16
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.5%
3/40 • Number of events 5
|
12.5%
5/40 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.0%
2/40 • Number of events 2
|
7.5%
3/40 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.5%
1/40 • Number of events 1
|
12.5%
5/40 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.5%
1/40 • Number of events 3
|
7.5%
3/40 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.0%
2/40 • Number of events 2
|
17.5%
7/40 • Number of events 8
|
|
Vascular disorders
Hypertension
|
5.0%
2/40 • Number of events 3
|
25.0%
10/40 • Number of events 21
|
Additional Information
Dr. Jaishri Blakely
Sidney Kimmel Comprehensive Cancer Center
Phone: (410) 955-8893
Results disclosure agreements
- Principal investigator is a sponsor employee In accordance with the ABTC publication, JHU will submit the draft of any proposed publication to ImClone at least thirty (30) days prior to submission for publication and agrees to withhold any such submission for an additional period, not to exceed ninety (90) days to allow ImClone to file patent applications. If Confidential Information is in the publication, it will notify JHU, which will insure such Confidential Information is redacted.
- Publication restrictions are in place
Restriction type: OTHER