Trial Outcomes & Findings for Bavituximab With Radiation and Temozolomide for Patients With Newly Diagnosed Glioblastoma (NCT NCT03139916)
NCT ID: NCT03139916
Last Updated: 2024-05-16
Results Overview
Overall survival is defined as the time from study entry to death from any cause. OS12 is the percentage of subjects who are alive 12 months after study entry. Data for subjects who are lost to follow up prior to documented death will be counted as deaths at the last assessment date when the subject is known to be alive.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
12 months
Results posted on
2024-05-16
Participant Flow
Participant milestones
| Measure |
Bavituximab + Standard of Care Radiation + Temozolomide
Cycle 1 consists of 6 weeks (42 days) of chemoradiation. Radiation therapy is administered per standard of care. Bavituxumab 3 mg/kg IV administration starts during the 1st week of chemoradiation and continues weekly. Temozolomide 75/m2 is administered orally once daily.
Cycle 2 is 4 weeks (28 days) long and Bavituxumab 3 mg/kg IV administration occurs weekly.
Cycle 3 and beyond are each 4 weeks (28 days) long. Bavituxumab 3 mg/kg IV administration occurs weekly for a cumulative total of 18 weeks; treatment may continue beyond 18 weeks at the discretion of the treating physician if the participant is deriving clinical benefit. Temozolomide 150-200 mg/m2 is administered orally once daily on days 1-5 in cycles 3 and 4.
|
|---|---|
|
Overall Study
STARTED
|
36
|
|
Overall Study
COMPLETED
|
33
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Bavituximab + Standard of Care Radiation + Temozolomide
Cycle 1 consists of 6 weeks (42 days) of chemoradiation. Radiation therapy is administered per standard of care. Bavituxumab 3 mg/kg IV administration starts during the 1st week of chemoradiation and continues weekly. Temozolomide 75/m2 is administered orally once daily.
Cycle 2 is 4 weeks (28 days) long and Bavituxumab 3 mg/kg IV administration occurs weekly.
Cycle 3 and beyond are each 4 weeks (28 days) long. Bavituxumab 3 mg/kg IV administration occurs weekly for a cumulative total of 18 weeks; treatment may continue beyond 18 weeks at the discretion of the treating physician if the participant is deriving clinical benefit. Temozolomide 150-200 mg/m2 is administered orally once daily on days 1-5 in cycles 3 and 4.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Clinical progression prior to start of study treatment
|
1
|
Baseline Characteristics
Bavituximab With Radiation and Temozolomide for Patients With Newly Diagnosed Glioblastoma
Baseline characteristics by cohort
| Measure |
Bavituximab + Standard of Care Radiation + Temozolomide
n=33 Participants
Cycle 1 consists of 6 weeks (42 days) of chemoradiation. Radiation therapy is administered per standard of care. Bavituxumab 3 mg/kg IV administration starts during the 1st week of chemoradiation and continues weekly. Temozolomide 75/m2 is administered orally once daily.
Cycle 2 is 4 weeks (28 days) long and Bavituxumab 3 mg/kg IV administration occurs weekly.
Cycle 3 and beyond are each 4 weeks (28 days) long. Bavituxumab 3 mg/kg IV administration occurs weekly for a cumulative total of 18 weeks; treatment may continue beyond 18 weeks at the discretion of the treating physician if the participant is deriving clinical benefit. Temozolomide 150-200 mg/m2 is administered orally once daily on days 1-5 in cycles 3 and 4.
|
|---|---|
|
Age, Continuous
|
59 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsOverall survival is defined as the time from study entry to death from any cause. OS12 is the percentage of subjects who are alive 12 months after study entry. Data for subjects who are lost to follow up prior to documented death will be counted as deaths at the last assessment date when the subject is known to be alive.
Outcome measures
| Measure |
Bavituximab + Standard of Care Radiation + Temozolomide
n=33 Participants
Cycle 1 consists of 6 weeks (42 days) of chemoradiation. Radiation therapy is administered per standard of care. Bavituxumab 3 mg/kg IV administration starts during the 1st week of chemoradiation and continues weekly. Temozolomide 75/m2 is administered orally once daily.
Cycle 2 is 4 weeks (28 days) long and Bavituxumab 3 mg/kg IV administration occurs weekly.
Cycle 3 and beyond are each 4 weeks (28 days) long. Bavituxumab 3 mg/kg IV administration occurs weekly for a cumulative total of 18 weeks; treatment may continue beyond 18 weeks at the discretion of the treating physician if the participant is deriving clinical benefit. Temozolomide 150-200 mg/m2 is administered orally once daily on days 1-5 in cycles 3 and 4.
|
|---|---|
|
Overall Survival at 12 Months (OS12)
|
72.7 percentage of participants
Interval 59.0 to 90.0
|
SECONDARY outcome
Timeframe: every 3 months for 5 yearsPopulation: Out of 33 patients, 26 patients had measurable disease at baseline per RANO criteria.
Radiographic response (RR) is defined as a complete response or partial response per RANO (Response assessment in neuro-oncology) criteria with incorporation of iRANO (immunotherapy response assessment for neuro-oncology) criteria. The radiographic response rate is the percentage of subjects who achieved radiographic response as defined above.
Outcome measures
| Measure |
Bavituximab + Standard of Care Radiation + Temozolomide
n=26 Participants
Cycle 1 consists of 6 weeks (42 days) of chemoradiation. Radiation therapy is administered per standard of care. Bavituxumab 3 mg/kg IV administration starts during the 1st week of chemoradiation and continues weekly. Temozolomide 75/m2 is administered orally once daily.
Cycle 2 is 4 weeks (28 days) long and Bavituxumab 3 mg/kg IV administration occurs weekly.
Cycle 3 and beyond are each 4 weeks (28 days) long. Bavituxumab 3 mg/kg IV administration occurs weekly for a cumulative total of 18 weeks; treatment may continue beyond 18 weeks at the discretion of the treating physician if the participant is deriving clinical benefit. Temozolomide 150-200 mg/m2 is administered orally once daily on days 1-5 in cycles 3 and 4.
|
|---|---|
|
Radiographic Response Rate
|
4 Participants
|
SECONDARY outcome
Timeframe: every 3 months for up to 5 yearsProgression free survival is defined as the time of study entry to time of disease progression, or death due to any cause. Data for subjects who are lost to follow up will be censored at the date when the subject is last known to be alive. PFS results below are reported up to the data cutoff in May 2021.
Outcome measures
| Measure |
Bavituximab + Standard of Care Radiation + Temozolomide
n=33 Participants
Cycle 1 consists of 6 weeks (42 days) of chemoradiation. Radiation therapy is administered per standard of care. Bavituxumab 3 mg/kg IV administration starts during the 1st week of chemoradiation and continues weekly. Temozolomide 75/m2 is administered orally once daily.
Cycle 2 is 4 weeks (28 days) long and Bavituxumab 3 mg/kg IV administration occurs weekly.
Cycle 3 and beyond are each 4 weeks (28 days) long. Bavituxumab 3 mg/kg IV administration occurs weekly for a cumulative total of 18 weeks; treatment may continue beyond 18 weeks at the discretion of the treating physician if the participant is deriving clinical benefit. Temozolomide 150-200 mg/m2 is administered orally once daily on days 1-5 in cycles 3 and 4.
|
|---|---|
|
Progression Free Survival (PFS)
|
6.9 months
Interval 6.2 to 9.7
|
SECONDARY outcome
Timeframe: Up to 5 yearsOverall survival is defined as the time of study entry to death from any cause. Data for subjects who are lost to follow up will be censored at the date when the subject is last known to be alive. OS results below are reported up to the data cutoff in May 2021.
Outcome measures
| Measure |
Bavituximab + Standard of Care Radiation + Temozolomide
n=33 Participants
Cycle 1 consists of 6 weeks (42 days) of chemoradiation. Radiation therapy is administered per standard of care. Bavituxumab 3 mg/kg IV administration starts during the 1st week of chemoradiation and continues weekly. Temozolomide 75/m2 is administered orally once daily.
Cycle 2 is 4 weeks (28 days) long and Bavituxumab 3 mg/kg IV administration occurs weekly.
Cycle 3 and beyond are each 4 weeks (28 days) long. Bavituxumab 3 mg/kg IV administration occurs weekly for a cumulative total of 18 weeks; treatment may continue beyond 18 weeks at the discretion of the treating physician if the participant is deriving clinical benefit. Temozolomide 150-200 mg/m2 is administered orally once daily on days 1-5 in cycles 3 and 4.
|
|---|---|
|
Overall Survival (OS)
|
15.4 months
Interval 13.3 to 23.6
|
Adverse Events
Bavituximab + Standard of Care Radiation + Temozolomide
Serious events: 9 serious events
Other events: 33 other events
Deaths: 29 deaths
Serious adverse events
| Measure |
Bavituximab + Standard of Care Radiation + Temozolomide
n=36 participants at risk
Cycle 1 consists of 6 weeks (42 days) of chemoradiation. Radiation therapy is administered per standard of care. Bavituxumab 3 mg/kg IV administration starts during the 1st week of chemoradiation and continues weekly. Temozolomide 75/m2 is administered orally once daily.
Cycle 2 is 4 weeks (28 days) long and Bavituxumab 3 mg/kg IV administration occurs weekly.
Cycle 3 and beyond are each 4 weeks (28 days) long. Bavituxumab 3 mg/kg IV administration occurs weekly for a cumulative total of 18 weeks; treatment may continue beyond 18 weeks at the discretion of the treating physician if the participant is deriving clinical benefit. Temozolomide 150-200 mg/m2 is administered orally once daily on days 1-5 in cycles 3 and 4.
|
|---|---|
|
Nervous system disorders
Cognitive disturbance
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Nervous system disorders
Hydrocephalus
|
5.6%
2/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Nervous system disorders
Somnolence
|
5.6%
2/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Psychiatric disorders
Confusion
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Eye disorders
Eye disorders - Other, specify
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
General disorders
Fever
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Gastrointestinal disorders
Gastritis
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Nervous system disorders
Headache
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Nervous system disorders
Seizure
|
8.3%
3/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Skin and subcutaneous tissue disorders
Skin/subcutaneous tissue disorders; Other, specify
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
Other adverse events
| Measure |
Bavituximab + Standard of Care Radiation + Temozolomide
n=36 participants at risk
Cycle 1 consists of 6 weeks (42 days) of chemoradiation. Radiation therapy is administered per standard of care. Bavituxumab 3 mg/kg IV administration starts during the 1st week of chemoradiation and continues weekly. Temozolomide 75/m2 is administered orally once daily.
Cycle 2 is 4 weeks (28 days) long and Bavituxumab 3 mg/kg IV administration occurs weekly.
Cycle 3 and beyond are each 4 weeks (28 days) long. Bavituxumab 3 mg/kg IV administration occurs weekly for a cumulative total of 18 weeks; treatment may continue beyond 18 weeks at the discretion of the treating physician if the participant is deriving clinical benefit. Temozolomide 150-200 mg/m2 is administered orally once daily on days 1-5 in cycles 3 and 4.
|
|---|---|
|
General disorders
General disorders and administration site conditions - Other, specify
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
13.9%
5/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Musculoskeletal and connective tissue disorders
Growth suppression
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Nervous system disorders
Headache
|
50.0%
18/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Renal and urinary disorders
Hematuria
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
8.3%
3/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Nervous system disorders
Hydrocephalus
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
19.4%
7/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Gastrointestinal disorders
Abdominal pain
|
8.3%
3/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Psychiatric disorders
Agitation
|
5.6%
2/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Nervous system disorders
Akathisia
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Investigations
Alanine aminotransferase increased
|
25.0%
9/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Investigations
Alkaline phosphatase increased
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Immune system disorders
Allergic reaction
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
12/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Blood and lymphatic system disorders
Anemia
|
16.7%
6/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Metabolism and nutrition disorders
Anorexia
|
25.0%
9/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Psychiatric disorders
Anxiety
|
22.2%
8/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.1%
4/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
9/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Nervous system disorders
Ataxia
|
5.6%
2/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
3/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Renal and urinary disorders
Bladder spasm
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Investigations
Blood bilirubin increased
|
5.6%
2/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Eye disorders
Blurred vision
|
11.1%
4/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Nervous system disorders
Cognitive disturbance
|
11.1%
4/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Gastrointestinal disorders
Colonic ulcer
|
5.6%
2/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Nervous system disorders
Concentration impairment
|
5.6%
2/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Psychiatric disorders
Confusion
|
13.9%
5/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Infections and infestations
Conjunctivitis infective
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Gastrointestinal disorders
Constipation
|
63.9%
23/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.9%
5/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Investigations
CPK increased
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Investigations
Creatinine increased
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Endocrine disorders
Cushingoid
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
6/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Psychiatric disorders
Delirium
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Psychiatric disorders
Depression
|
8.3%
3/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
6/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Nervous system disorders
Dizziness
|
33.3%
12/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Eye disorders
Dry eye
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.6%
2/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Gastrointestinal disorders
Duodenal hemorrhage
|
8.3%
3/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Nervous system disorders
Dysgeusia
|
8.3%
3/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Gastrointestinal disorders
Dysphagia
|
13.9%
5/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Nervous system disorders
Dysphasia
|
5.6%
2/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.1%
4/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Ear and labyrinth disorders
Ear pain
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Nervous system disorders
Edema cerebral
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
General disorders
Edema limbs
|
5.6%
2/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
5.6%
2/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Ear and labyrinth disorders
External ear pain
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Eye disorders
Eye disorders - Other, specify
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Infections and infestations
Eye infection
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Nervous system disorders
Facial muscle weakness
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Injury, poisoning and procedural complications
Fall
|
8.3%
3/36 • Up to 5 years, starting at date of first treatment administration.
|
|
General disorders
Fatigue
|
75.0%
27/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Gastrointestinal disorders
Fecal incontinence
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
General disorders
Fever
|
5.6%
2/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Eye disorders
Floaters
|
8.3%
3/36 • Up to 5 years, starting at date of first treatment administration.
|
|
General disorders
Flu like symptoms
|
5.6%
2/36 • Up to 5 years, starting at date of first treatment administration.
|
|
General disorders
Gait disturbance
|
19.4%
7/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
13.9%
5/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Vascular disorders
Hypertension
|
13.9%
5/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
5.6%
2/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
5.6%
2/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
5.6%
2/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
11.1%
4/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
8.3%
3/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Vascular disorders
Hypotension
|
11.1%
4/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Psychiatric disorders
Insomnia
|
33.3%
12/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Nervous system disorders
Intracranial hemorrhage
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Investigations
Investigations - Other, specify
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Investigations
Investigations
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
General disorders
Irritability
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Infections and infestations
Lip infection (cold sore)
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
General disorders
Localized edema
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Investigations
Lymphocyte count decreased
|
27.8%
10/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Nervous system disorders
Memory impairment
|
33.3%
12/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Infections and infestations
Mucosal infection
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
13.9%
5/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
13.9%
5/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.3%
3/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.6%
2/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
18/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
8.3%
3/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Nervous system disorders
Hemiparesis
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Nervous system disorders
Neuralgia
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Investigations
Neutrophil count decreased
|
22.2%
8/36 • Up to 5 years, starting at date of first treatment administration.
|
|
General disorders
Non-cardiac chest pain
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Nervous system disorders
Nystagmus
|
5.6%
2/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Metabolism and nutrition disorders
Obesity
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
General disorders
Pain
|
8.3%
3/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Cardiac disorders
Palpitations
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Infections and infestations
Papulopustular rash
|
5.6%
2/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Nervous system disorders
Paresthesia
|
5.6%
2/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Infections and infestations
Paronychia
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Investigations
Platelet count decreased
|
33.3%
12/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
13.9%
5/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
8.3%
3/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
19.4%
7/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Nervous system disorders
Seizure
|
22.2%
8/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Cardiac disorders
Sinus bradycardia
|
13.9%
5/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Nervous system disorders
Sinus pain
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Cardiac disorders
Sinus tachycardia
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Skin and subcutaneous tissue disorders
Skin/subcutaneous tissue disorders; Other, specify
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Nervous system disorders
Somnolence
|
11.1%
4/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Gastrointestinal disorders
Stomach pain
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Ear and labyrinth disorders
Tinnitus
|
5.6%
2/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Nervous system disorders
Tremor
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Infections and infestations
Upper respiratory infection
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Renal and urinary disorders
Urinary frequency
|
8.3%
3/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Renal and urinary disorders
Urinary incontinence
|
8.3%
3/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Infections and infestations
Urinary tract infection
|
11.1%
4/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Renal and urinary disorders
Urinary tract pain
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Nervous system disorders
Vasovagal reaction
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
6/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Eye disorders
Watering eyes
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Investigations
Weight gain
|
8.3%
3/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Investigations
Weight loss
|
13.9%
5/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Investigations
White blood cell decreased
|
30.6%
11/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Eye disorders
Right hemianopsia
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
|
Investigations
Myoglobin increase
|
2.8%
1/36 • Up to 5 years, starting at date of first treatment administration.
|
Additional Information
Elizabeth R. Gerstner, MD
Massachusetts General Hospital
Phone: 617-724-8770
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place