Trial Outcomes & Findings for A Study of PD 0332991 in Patients With Recurrent Rb Positive Glioblastoma (NCT NCT01227434)
NCT ID: NCT01227434
Last Updated: 2015-07-17
Results Overview
Efficacy of the small molecule CDK4/6 inhibitor PD 0332991 in patients with recurrent glioblastoma multiforme or gliosarcoma who are Rb positive was measured by progression free survival. A total of 30 patients was intended to be treated; up to 15 patients were to undergo a planned, intended surgical resection and receive drug for 7 days prior to surgery, followed by drug after recovery from surgery; and up to 15 patients were to receive drug without a planned surgical procedure.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
23 participants
Primary outcome timeframe
up to 142 weeks
Results posted on
2015-07-17
Participant Flow
Of 23 participants consented, 1 was found ineligible prior to randomization
Participant milestones
| Measure |
Surgical Group
PD 0332991 125 mg daily for 7 days prior to an indicated, surgical resection for progression, and resume drug at the same dose after recovery from surgery on a repeating schedule of 21 consecutive days of drug followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
|
Non-surgical Group
Patients not in need of surgery treated with PD 0332991 at a dose of 125 mg daily for 21 consecutive days followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
16
|
|
Overall Study
COMPLETED
|
6
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of PD 0332991 in Patients With Recurrent Rb Positive Glioblastoma
Baseline characteristics by cohort
| Measure |
Surgical Group
n=6 Participants
PD 0332991 125 mg daily for 7 days prior to an indicated, intended surgical resection for progression, and then resume drug at the same dose after recovery from surgery on a repeating schedule of 21 consecutive days of drug followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
|
Non-surgical Group
n=16 Participants
Patients not in need of surgery treated with PD 0332991 125 mg daily for 21 consecutive days followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
16 participants
n=7 Participants
|
22 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 142 weeksEfficacy of the small molecule CDK4/6 inhibitor PD 0332991 in patients with recurrent glioblastoma multiforme or gliosarcoma who are Rb positive was measured by progression free survival. A total of 30 patients was intended to be treated; up to 15 patients were to undergo a planned, intended surgical resection and receive drug for 7 days prior to surgery, followed by drug after recovery from surgery; and up to 15 patients were to receive drug without a planned surgical procedure.
Outcome measures
| Measure |
Surgical Group
n=6 Participants
PD 0332991 125 mg daily for 7 days prior to an indicated, intended surgical resection for progression, and then resume drug at the same dose after recovery from surgery on a repeating schedule of 21 consecutive days of drug followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
|
Non-surgical Group
n=16 Participants
Patients not requiring surgery treated with PD 0332991 125 mg daily for 21 consecutive days followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
|
|---|---|---|
|
Progression Free Survival
|
4 weeks
Interval 3.0 to 6.0
|
14 weeks
Interval 1.0 to 142.0
|
SECONDARY outcome
Timeframe: 1-2 yearsThe number of participants with protocol related toxicity described by CTCAE version 4.0
Outcome measures
| Measure |
Surgical Group
n=6 Participants
PD 0332991 125 mg daily for 7 days prior to an indicated, intended surgical resection for progression, and then resume drug at the same dose after recovery from surgery on a repeating schedule of 21 consecutive days of drug followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
|
Non-surgical Group
n=16 Participants
Patients not requiring surgery treated with PD 0332991 125 mg daily for 21 consecutive days followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
|
|---|---|---|
|
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
|
6 participants
|
16 participants
|
Adverse Events
Surgical Group
Serious events: 5 serious events
Other events: 4 other events
Deaths: 0 deaths
Non-surgical Group
Serious events: 4 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Surgical Group
n=6 participants at risk
PD 0332991 125 mg daily for 7 days prior to an indicated, intended surgical resection for progression, and then resume drug at the same dose after recovery from surgery on a repeating schedule of 21 consecutive days of drug followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
|
Non-surgical Group
n=16 participants at risk
Patients not requiring surgery treated with PD 0332991 125 mg daily for 21 consecutive days followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
|
|---|---|---|
|
General disorders
Death NOS
|
16.7%
1/6 • Number of events 1 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
12.5%
2/16 • Number of events 2 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Infections and infestations
Meningitis
|
16.7%
1/6 • Number of events 1 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
0.00%
0/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Infections and infestations
Wound Infection
|
16.7%
1/6 • Number of events 2 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
0.00%
0/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness
|
16.7%
1/6 • Number of events 1 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
0.00%
0/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Nervous system disorders
Cerebral Spinal Fluid Leakage
|
16.7%
1/6 • Number of events 1 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
0.00%
0/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Nervous system disorders
Cognitive disturbance
|
16.7%
1/6 • Number of events 1 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
0.00%
0/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • Number of events 2 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
6.2%
1/16 • Number of events 1 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Nervous system disorders
Seizure
|
33.3%
2/6 • Number of events 2 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
0.00%
0/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Nervous system disorders
Peripheral Motor Neuropathy
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
6.2%
1/16 • Number of events 1 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
6.2%
1/16 • Number of events 1 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Gastrointestinal disorders
Mucositis
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
6.2%
1/16 • Number of events 1 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Infections and infestations
Lung Infection
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
6.2%
1/16 • Number of events 1 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
Other adverse events
| Measure |
Surgical Group
n=6 participants at risk
PD 0332991 125 mg daily for 7 days prior to an indicated, intended surgical resection for progression, and then resume drug at the same dose after recovery from surgery on a repeating schedule of 21 consecutive days of drug followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
|
Non-surgical Group
n=16 participants at risk
Patients not requiring surgery treated with PD 0332991 125 mg daily for 21 consecutive days followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
6.2%
1/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Cardiac disorders
Sinus tachycardia
|
16.7%
1/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
12.5%
2/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Ear and labyrinth disorders
Tinnitus
|
16.7%
1/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
0.00%
0/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Endocrine disorders
Cushingoid
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
6.2%
1/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Eye disorders
Blurred vision
|
16.7%
1/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
0.00%
0/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Eye disorders
Right upper quadrant defect
|
16.7%
1/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
0.00%
0/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
6.2%
1/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
18.8%
3/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
1/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
0.00%
0/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
6.2%
1/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Gastrointestinal disorders
Stool urgency
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
6.2%
1/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Gastrointestinal disorders
Food craving
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
6.2%
1/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Gastrointestinal disorders
Stomach discomfort
|
16.7%
1/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
0.00%
0/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
6.2%
1/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Gastrointestinal disorders
Mucositis Oral
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
25.0%
4/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
18.8%
3/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
12.5%
2/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
General disorders
Death NOS
|
16.7%
1/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
12.5%
2/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
General disorders
Edema limbs
|
16.7%
1/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
6.2%
1/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
General disorders
Fatigue
|
33.3%
2/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
43.8%
7/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
General disorders
Flu like symptoms
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
6.2%
1/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
General disorders
Gait disturbance
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
12.5%
2/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
General disorders
Groin pain
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
12.5%
2/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
6.2%
1/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Infections and infestations
Eye infection
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
6.2%
1/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Infections and infestations
Lung infection
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
6.2%
1/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Infections and infestations
Meningitis
|
16.7%
1/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
0.00%
0/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Infections and infestations
Skin infection
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
6.2%
1/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
6.2%
1/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Infections and infestations
Wound infection
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
6.2%
1/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
6.2%
1/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
2/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
0.00%
0/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
1/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
0.00%
0/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Investigations
Lymphocyte count decreased
|
33.3%
2/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
43.8%
7/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
50.0%
8/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Investigations
Platelet count decreased
|
16.7%
1/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
31.2%
5/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Investigations
Weight gain
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
12.5%
2/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Investigations
White blood cell decreased
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
31.2%
5/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
6.2%
1/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
6.2%
1/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
6.2%
1/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
16.7%
1/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
0.00%
0/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
6.2%
1/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
16.7%
1/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
12.5%
2/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness-left sided
|
16.7%
1/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
12.5%
2/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
6.2%
1/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
16.7%
1/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
0.00%
0/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
16.7%
1/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
12.5%
2/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Musculoskeletal and connective tissue disorders
Hip and shoulder pain
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
6.2%
1/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Musculoskeletal and connective tissue disorders
Pain in chest and shoulder-from fall
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
6.2%
1/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
1/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
6.2%
1/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
6.2%
1/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Nervous system disorders
Ataxia
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
12.5%
2/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
16.7%
1/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
0.00%
0/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Nervous system disorders
Cognitive disturbance
|
33.3%
2/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
6.2%
1/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
6.2%
1/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Nervous system disorders
Dysphasia
|
16.7%
1/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
18.8%
3/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Nervous system disorders
Facial nerve disorder
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
12.5%
2/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
50.0%
8/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Nervous system disorders
Hydrocephalus
|
16.7%
1/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
0.00%
0/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Nervous system disorders
Intracranial hemorrhage
|
16.7%
1/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
0.00%
0/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
18.8%
3/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Nervous system disorders
Trouble reading
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
6.2%
1/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Nervous system disorders
Neglect
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
6.2%
1/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Nervous system disorders
Decreased coordination
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
6.2%
1/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Nervous system disorders
L UQ VF neglect
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
6.2%
1/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Nervous system disorders
Intraventricular hemorrhage
|
16.7%
1/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
0.00%
0/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Nervous system disorders
Peripheral motor neuropathy
|
16.7%
1/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
0.00%
0/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
6.2%
1/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Nervous system disorders
Seizure
|
33.3%
2/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
0.00%
0/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Nervous system disorders
Spasticity
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
6.2%
1/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Nervous system disorders
Tremor
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
6.2%
1/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Psychiatric disorders
Agitation
|
16.7%
1/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
0.00%
0/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Psychiatric disorders
Anxiety
|
16.7%
1/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
18.8%
3/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Psychiatric disorders
Confusion
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
6.2%
1/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Psychiatric disorders
Depression
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
12.5%
2/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Psychiatric disorders
Insomnia
|
16.7%
1/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
18.8%
3/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
6.2%
1/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
18.8%
3/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
6.2%
1/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Reproductive system and breast disorders
Painful lump
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
6.2%
1/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
16.7%
1/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
6.2%
1/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
6.2%
1/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
12.5%
2/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
6.2%
1/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
18.8%
3/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
6.2%
1/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
6.2%
1/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
6.2%
1/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
6.2%
1/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
6.2%
1/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
6.2%
1/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
6.2%
1/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
16.7%
1/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
0.00%
0/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
6.2%
1/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Skin and subcutaneous tissue disorders
Strial rash
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
6.2%
1/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Skin and subcutaneous tissue disorders
Minor skin changes
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
6.2%
1/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
6.2%
1/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Vascular disorders
Hematoma
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
6.2%
1/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Vascular disorders
Thromboembolic event
|
16.7%
1/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
0.00%
0/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
|
Vascular disorders
Deep vein thrombosis (DVT)
|
0.00%
0/6 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
6.2%
1/16 • 3 years
Adverse events were collected from date of first drug, until 30 days following completion of study treatment
|
Additional Information
Michael Prados, MD
University of California San Francisco
Phone: 4154767217
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place