Trial Outcomes & Findings for GDC-0449 in Treating Patients With Recurrent Glioblastoma Multiforme That Can Be Removed by Surgery (NCT NCT00980343)
NCT ID: NCT00980343
Last Updated: 2017-08-16
Results Overview
Estimated using Kaplan Meier curves. six months calculated from date of treatment onset post-operatively. MRI scan at 6 months must be free of progression Progressive disease Progressive neurological abnormalities not explained by other causes or greater than 25% increase in size of tumor or if new lesion.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
44 participants
Primary outcome timeframe
6 months
Results posted on
2017-08-16
Participant Flow
Subjects were enrolled from March 2010 to April 2011. Subjects were recruited from outpatient cancer centers but all patients needed surgery to participate in this study.
Participant milestones
| Measure |
Arm I (Pre-surgery Vismodegib)
Patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily for 7 days before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: pharmacological study; laboratory biomarker analysis
vismodegib: Given orally
therapeutic conventional surgery: undergo surgery
laboratory biomarker analysis: correlative studies
pharmacological study: correlative studies
|
Arm II (no Vismodegib Pre-surgery)
Patients do not receive treatment before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: laboratory biomarker analysis
vismodegib: Given orally
therapeutic conventional surgery: undergo surgery
laboratory biomarker analysis: correlative studies
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
23
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
Arm I (Pre-surgery Vismodegib)
Patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily for 7 days before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: pharmacological study; laboratory biomarker analysis
vismodegib: Given orally
therapeutic conventional surgery: undergo surgery
laboratory biomarker analysis: correlative studies
pharmacological study: correlative studies
|
Arm II (no Vismodegib Pre-surgery)
Patients do not receive treatment before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: laboratory biomarker analysis
vismodegib: Given orally
therapeutic conventional surgery: undergo surgery
laboratory biomarker analysis: correlative studies
|
|---|---|---|
|
Overall Study
no tumor at surgery - treatment effect
|
1
|
3
|
Baseline Characteristics
GDC-0449 in Treating Patients With Recurrent Glioblastoma Multiforme That Can Be Removed by Surgery
Baseline characteristics by cohort
| Measure |
Arm I (Pre-surgery Vismodegib)
n=20 Participants
Patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily for 7 days before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: pharmacological study; laboratory biomarker analysis
vismodegib: Given orally
therapeutic conventional surgery: undergo surgery
laboratory biomarker analysis: correlative studies
pharmacological study: correlative studies
|
Arm II (no Vismodegib Pre-surgery)
n=20 Participants
Patients do not receive treatment before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: laboratory biomarker analysis
vismodegib: Given orally
therapeutic conventional surgery: undergo surgery
laboratory biomarker analysis: correlative studies
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 years
n=5 Participants
|
60 years
n=7 Participants
|
59 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Karnofsky Performance Status Scale
|
80 units on a scale
n=5 Participants
|
90 units on a scale
n=7 Participants
|
80 units on a scale
n=5 Participants
|
|
Mini Mental State Exam (MMSE)
|
28 units on a scale
n=5 Participants
|
29 units on a scale
n=7 Participants
|
28 units on a scale
n=5 Participants
|
|
Measurable disease
Yes
|
18 participants
n=5 Participants
|
18 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Measurable disease
No
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Number of Prior Treatments
1 Prior Treatment
|
12 participants
n=5 Participants
|
15 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Number of Prior Treatments
2 Prior Treatments
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Number of Prior Treatments
4 Prior Treatments
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsEstimated using Kaplan Meier curves. six months calculated from date of treatment onset post-operatively. MRI scan at 6 months must be free of progression Progressive disease Progressive neurological abnormalities not explained by other causes or greater than 25% increase in size of tumor or if new lesion.
Outcome measures
| Measure |
Arm I (Pre-surgery Vismodegib)
n=20 Participants
Patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily for 7 days before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: pharmacological study; laboratory biomarker analysis
vismodegib: Given orally
therapeutic conventional surgery: undergo surgery
laboratory biomarker analysis: correlative studies
pharmacological study: correlative studies
|
Arm II (no Vismodegib Pre-surgery)
n=20 Participants
Patients do not receive treatment before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: laboratory biomarker analysis
vismodegib: Given orally
therapeutic conventional surgery: undergo surgery
laboratory biomarker analysis: correlative studies
|
|---|---|---|
|
6 Months Progression-free Survival (PFS)
|
0 percentage of patients
Interval 0.0 to 16.8
|
5 percentage of patients
Interval 0.1 to 24.9
|
SECONDARY outcome
Timeframe: 3 yearsThe overall failure rate will be estimated along with 95% confidence intervals. A median time of survival will be estimated using standard methods.. Start date based on onset of treatment.
Outcome measures
| Measure |
Arm I (Pre-surgery Vismodegib)
n=20 Participants
Patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily for 7 days before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: pharmacological study; laboratory biomarker analysis
vismodegib: Given orally
therapeutic conventional surgery: undergo surgery
laboratory biomarker analysis: correlative studies
pharmacological study: correlative studies
|
Arm II (no Vismodegib Pre-surgery)
n=20 Participants
Patients do not receive treatment before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: laboratory biomarker analysis
vismodegib: Given orally
therapeutic conventional surgery: undergo surgery
laboratory biomarker analysis: correlative studies
|
|---|---|---|
|
Overall Survival Time
|
7.8 months
Interval 3.7 to 10.2
|
7.6 months
Interval 5.0 to 13.1
|
SECONDARY outcome
Timeframe: evaluated every 8 weeks - 1 yearPopulation: 3 subjects not evaluable for radiographic response Arm 1 and 4 subjects not evaluable for radiographic response in Arm 2
The Macdonald criteria, roughly similarly to other systems, divides response into 4 types of response based on imaging (MRI) and clinical features 1: complete response; 2: partial response; 3:stable disease; 4:progression Complete response imaging features: disappearance of all enhancing disease (measurable and non-measurable) sustained for at least 4 weeks; no new lesions clinical features; no corticosteroids; clinically stable or improved Partial response imaging features: 50% or more decrease of all measurable enhancing lesions sustained for at least 4 weeks: no new lesions clinical features: stable or reduced corticosteroids; clinically stable or improved Stable disease imaging features: does not qualify for complete response, partial response or progression clinical features: clinically stable Progression imaging features: 25% of more increase in enhancing lesions; any new lesions clinical features: clinical deterioration
Outcome measures
| Measure |
Arm I (Pre-surgery Vismodegib)
n=20 Participants
Patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily for 7 days before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: pharmacological study; laboratory biomarker analysis
vismodegib: Given orally
therapeutic conventional surgery: undergo surgery
laboratory biomarker analysis: correlative studies
pharmacological study: correlative studies
|
Arm II (no Vismodegib Pre-surgery)
n=20 Participants
Patients do not receive treatment before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: laboratory biomarker analysis
vismodegib: Given orally
therapeutic conventional surgery: undergo surgery
laboratory biomarker analysis: correlative studies
|
|---|---|---|
|
Best Tumor Response Assessed by the Modified Macdonald Radiographic Response Criteria
Progressive Disease
|
13 participants
|
11 participants
|
|
Best Tumor Response Assessed by the Modified Macdonald Radiographic Response Criteria
Stable Disease
|
4 participants
|
5 participants
|
SECONDARY outcome
Timeframe: 30 days from last dose of drug treatment - 1.5 yearsNCI CTCAE grade 3 or 4 possible, probable or definitely related events Grade 3 - severe Grade 4 - life threatening
Outcome measures
| Measure |
Arm I (Pre-surgery Vismodegib)
n=20 Participants
Patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily for 7 days before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: pharmacological study; laboratory biomarker analysis
vismodegib: Given orally
therapeutic conventional surgery: undergo surgery
laboratory biomarker analysis: correlative studies
pharmacological study: correlative studies
|
Arm II (no Vismodegib Pre-surgery)
n=20 Participants
Patients do not receive treatment before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: laboratory biomarker analysis
vismodegib: Given orally
therapeutic conventional surgery: undergo surgery
laboratory biomarker analysis: correlative studies
|
|---|---|---|
|
Toxicity Incidence Grade 3 or 4 According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0
Lymphocyte count decrase gr3
|
10 percent of participants
|
0 percent of participants
|
|
Toxicity Incidence Grade 3 or 4 According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0
Stroke gr3
|
5 percent of participants
|
0 percent of participants
|
|
Toxicity Incidence Grade 3 or 4 According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0
abdominal infection gr3
|
5 percent of participants
|
0 percent of participants
|
|
Toxicity Incidence Grade 3 or 4 According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0
abdominal pain gr3
|
5 percent of participants
|
0 percent of participants
|
|
Toxicity Incidence Grade 3 or 4 According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0
atrial flutter gr3
|
5 percent of participants
|
0 percent of participants
|
SECONDARY outcome
Timeframe: 12 hours post-vismodegib administrationnumber of tumor-derived CD133 neurospheres undergoing proliferation and self-renewal
Outcome measures
| Measure |
Arm I (Pre-surgery Vismodegib)
n=20 Participants
Patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily for 7 days before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: pharmacological study; laboratory biomarker analysis
vismodegib: Given orally
therapeutic conventional surgery: undergo surgery
laboratory biomarker analysis: correlative studies
pharmacological study: correlative studies
|
Arm II (no Vismodegib Pre-surgery)
n=19 Participants
Patients do not receive treatment before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: laboratory biomarker analysis
vismodegib: Given orally
therapeutic conventional surgery: undergo surgery
laboratory biomarker analysis: correlative studies
|
|---|---|---|
|
Incidence of CD133+ Neurospheres by Arm
|
3 percent of CD133 Neuospheres
|
11 percent of CD133 Neuospheres
|
SECONDARY outcome
Timeframe: Pre-tumor resection and post tumor resection (12 hours)Population: only small number of samples and thus not enough to give useful information. Samples not processed for outcome and analysis was not performed. No numerical data to report
determined by Reverse transcription polymerase chain reaction (RT-PCR) and immunohistochemistry (IHC) (Gli-1, Gli-2, PATCH (PTCH-1b)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day of surgerysamples collected pre tumor resection (day of surgery) and post-tumor resection (day of surgery
Outcome measures
| Measure |
Arm I (Pre-surgery Vismodegib)
n=20 Participants
Patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily for 7 days before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: pharmacological study; laboratory biomarker analysis
vismodegib: Given orally
therapeutic conventional surgery: undergo surgery
laboratory biomarker analysis: correlative studies
pharmacological study: correlative studies
|
Arm II (no Vismodegib Pre-surgery)
Patients do not receive treatment before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: laboratory biomarker analysis
vismodegib: Given orally
therapeutic conventional surgery: undergo surgery
laboratory biomarker analysis: correlative studies
|
|---|---|---|
|
Determine Drug Effect (Pharmacokinetics) in Plasma for Arm 1
Plasma
|
7638 ng/ml
Standard Deviation 1759
|
—
|
|
Determine Drug Effect (Pharmacokinetics) in Plasma for Arm 1
Intra-tumoral level
|
3270 ng/ml
Standard Deviation 1326
|
—
|
Adverse Events
Arm I (Pre-surgery Vismodegib)
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Arm II (no Vismodegib Pre-surgery)
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm I (Pre-surgery Vismodegib)
n=20 participants at risk
Patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily for 7 days before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: pharmacological study; laboratory biomarker analysis
vismodegib: Given orally
therapeutic conventional surgery: undergo surgery
laboratory biomarker analysis: correlative studies
pharmacological study: correlative studies
|
Arm II (no Vismodegib Pre-surgery)
n=20 participants at risk
Patients do not receive treatment before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: laboratory biomarker analysis
vismodegib: Given orally
therapeutic conventional surgery: undergo surgery
laboratory biomarker analysis: correlative studies
|
|---|---|---|
|
Infections and infestations
abdominal infection
|
5.0%
1/20 • Number of events 1 • 1year
patients were treated pre and post surgery
|
0.00%
0/20 • 1year
patients were treated pre and post surgery
|
|
Gastrointestinal disorders
abdominal pain
|
5.0%
1/20 • Number of events 1 • 1year
patients were treated pre and post surgery
|
0.00%
0/20 • 1year
patients were treated pre and post surgery
|
|
Investigations
activated partial thromboplastin time prolonged
|
5.0%
1/20 • Number of events 1 • 1year
patients were treated pre and post surgery
|
0.00%
0/20 • 1year
patients were treated pre and post surgery
|
|
Investigations
alanine aminotransferase increased
|
20.0%
4/20 • Number of events 4 • 1year
patients were treated pre and post surgery
|
0.00%
0/20 • 1year
patients were treated pre and post surgery
|
|
Blood and lymphatic system disorders
anemia
|
15.0%
3/20 • Number of events 3 • 1year
patients were treated pre and post surgery
|
20.0%
4/20 • Number of events 4 • 1year
patients were treated pre and post surgery
|
|
Skin and subcutaneous tissue disorders
alopecia
|
0.00%
0/20 • 1year
patients were treated pre and post surgery
|
10.0%
2/20 • Number of events 2 • 1year
patients were treated pre and post surgery
|
|
Investigations
aspartate aminotransferase increased
|
5.0%
1/20 • Number of events 1 • 1year
patients were treated pre and post surgery
|
0.00%
0/20 • 1year
patients were treated pre and post surgery
|
|
Metabolism and nutrition disorders
anorexia
|
20.0%
4/20 • Number of events 4 • 1year
patients were treated pre and post surgery
|
25.0%
5/20 • Number of events 5 • 1year
patients were treated pre and post surgery
|
|
Cardiac disorders
atrial flutter
|
5.0%
1/20 • Number of events 1 • 1year
patients were treated pre and post surgery
|
0.00%
0/20 • 1year
patients were treated pre and post surgery
|
|
Musculoskeletal and connective tissue disorders
back pain
|
5.0%
1/20 • Number of events 1 • 1year
patients were treated pre and post surgery
|
5.0%
1/20 • Number of events 1 • 1year
patients were treated pre and post surgery
|
|
Gastrointestinal disorders
constipation
|
10.0%
2/20 • Number of events 2 • 1year
patients were treated pre and post surgery
|
15.0%
3/20 • Number of events 3 • 1year
patients were treated pre and post surgery
|
|
Gastrointestinal disorders
diarrhea
|
15.0%
3/20 • Number of events 3 • 1year
patients were treated pre and post surgery
|
10.0%
2/20 • Number of events 2 • 1year
patients were treated pre and post surgery
|
|
Nervous system disorders
dysgeusia
|
5.0%
1/20 • Number of events 1 • 1year
patients were treated pre and post surgery
|
0.00%
0/20 • 1year
patients were treated pre and post surgery
|
|
Nervous system disorders
dysphasia
|
5.0%
1/20 • Number of events 1 • 1year
patients were treated pre and post surgery
|
0.00%
0/20 • 1year
patients were treated pre and post surgery
|
|
Nervous system disorders
dizziness
|
0.00%
0/20 • 1year
patients were treated pre and post surgery
|
10.0%
2/20 • Number of events 2 • 1year
patients were treated pre and post surgery
|
|
Skin and subcutaneous tissue disorders
dry skin
|
0.00%
0/20 • 1year
patients were treated pre and post surgery
|
5.0%
1/20 • Number of events 1 • 1year
patients were treated pre and post surgery
|
|
Nervous system disorders
facial muscle weakness
|
5.0%
1/20 • Number of events 1 • 1year
patients were treated pre and post surgery
|
0.00%
0/20 • 1year
patients were treated pre and post surgery
|
|
General disorders
fatigue
|
35.0%
7/20 • Number of events 7 • 1year
patients were treated pre and post surgery
|
40.0%
8/20 • Number of events 8 • 1year
patients were treated pre and post surgery
|
|
Nervous system disorders
headache
|
5.0%
1/20 • Number of events 1 • 1year
patients were treated pre and post surgery
|
15.0%
3/20 • Number of events 3 • 1year
patients were treated pre and post surgery
|
|
Gastrointestinal disorders
gastroesophageal reflux disease
|
5.0%
1/20 • Number of events 1 • 1year
patients were treated pre and post surgery
|
0.00%
0/20 • 1year
patients were treated pre and post surgery
|
|
Metabolism and nutrition disorders
hypocalcemia
|
5.0%
1/20 • Number of events 1 • 1year
patients were treated pre and post surgery
|
5.0%
1/20 • Number of events 1 • 1year
patients were treated pre and post surgery
|
|
Metabolism and nutrition disorders
hypokalemia
|
5.0%
1/20 • Number of events 1 • 1year
patients were treated pre and post surgery
|
5.0%
1/20 • Number of events 1 • 1year
patients were treated pre and post surgery
|
|
Psychiatric disorders
insomnia
|
5.0%
1/20 • Number of events 1 • 1year
patients were treated pre and post surgery
|
5.0%
1/20 • Number of events 1 • 1year
patients were treated pre and post surgery
|
|
Renal and urinary disorders
hematuria
|
0.00%
0/20 • 1year
patients were treated pre and post surgery
|
5.0%
1/20 • Number of events 1 • 1year
patients were treated pre and post surgery
|
|
Metabolism and nutrition disorders
hyperglycemia
|
0.00%
0/20 • 1year
patients were treated pre and post surgery
|
10.0%
2/20 • Number of events 2 • 1year
patients were treated pre and post surgery
|
|
Metabolism and nutrition disorders
hypermagnesemia
|
0.00%
0/20 • 1year
patients were treated pre and post surgery
|
20.0%
4/20 • Number of events 4 • 1year
patients were treated pre and post surgery
|
|
Metabolism and nutrition disorders
hypophosphatemia
|
0.00%
0/20 • 1year
patients were treated pre and post surgery
|
5.0%
1/20 • Number of events 1 • 1year
patients were treated pre and post surgery
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal and connective tissue disorder
|
0.00%
0/20 • 1year
patients were treated pre and post surgery
|
5.0%
1/20 • Number of events 1 • 1year
patients were treated pre and post surgery
|
|
Investigations
lymphocyte count decrease
|
10.0%
2/20 • Number of events 2 • 1year
patients were treated pre and post surgery
|
5.0%
1/20 • Number of events 1 • 1year
patients were treated pre and post surgery
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
5.0%
1/20 • Number of events 1 • 1year
patients were treated pre and post surgery
|
0.00%
0/20 • 1year
patients were treated pre and post surgery
|
|
Gastrointestinal disorders
nausea
|
10.0%
2/20 • Number of events 2 • 1year
patients were treated pre and post surgery
|
25.0%
5/20 • Number of events 5 • 1year
patients were treated pre and post surgery
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
0.00%
0/20 • 1year
patients were treated pre and post surgery
|
5.0%
1/20 • Number of events 1 • 1year
patients were treated pre and post surgery
|
|
Investigations
neutrophile count decrease
|
5.0%
1/20 • Number of events 1 • 1year
patients were treated pre and post surgery
|
15.0%
3/20 • Number of events 3 • 1year
patients were treated pre and post surgery
|
|
General disorders
non-cardiac chest pain
|
0.00%
0/20 • 1year
patients were treated pre and post surgery
|
5.0%
1/20 • Number of events 1 • 1year
patients were treated pre and post surgery
|
|
Skin and subcutaneous tissue disorders
pain of skin
|
0.00%
0/20 • 1year
patients were treated pre and post surgery
|
5.0%
1/20 • Number of events 1 • 1year
patients were treated pre and post surgery
|
|
Investigations
platelet count decrease
|
15.0%
3/20 • Number of events 3 • 1year
patients were treated pre and post surgery
|
5.0%
1/20 • Number of events 1 • 1year
patients were treated pre and post surgery
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/20 • 1year
patients were treated pre and post surgery
|
5.0%
1/20 • Number of events 1 • 1year
patients were treated pre and post surgery
|
|
Skin and subcutaneous tissue disorders
rash acneiform
|
5.0%
1/20 • Number of events 1 • 1year
patients were treated pre and post surgery
|
5.0%
1/20 • Number of events 1 • 1year
patients were treated pre and post surgery
|
|
Nervous system disorders
stroke
|
5.0%
1/20 • Number of events 1 • 1year
patients were treated pre and post surgery
|
0.00%
0/20 • 1year
patients were treated pre and post surgery
|
|
Investigations
white blood cell decrease
|
10.0%
2/20 • Number of events 2 • 1year
patients were treated pre and post surgery
|
20.0%
4/20 • Number of events 4 • 1year
patients were treated pre and post surgery
|
|
Infections and infestations
urinary tract infection
|
0.00%
0/20 • 1year
patients were treated pre and post surgery
|
5.0%
1/20 • Number of events 1 • 1year
patients were treated pre and post surgery
|
|
Renal and urinary disorders
urine discoloration
|
0.00%
0/20 • 1year
patients were treated pre and post surgery
|
5.0%
1/20 • Number of events 1 • 1year
patients were treated pre and post surgery
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60