Trial Outcomes & Findings for Vorinostat in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme (NCT NCT00238303)
NCT ID: NCT00238303
Last Updated: 2014-05-23
Results Overview
Estimated using the Binomial point estimator (number of successes divided by the total number of evaluable patients) and the Binomial 95% confidence interval estimated by the exact method. Definition of progression: Bidimensionally measurable disease: \>25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions. Evaluable disease (i.e., contrast enhancing mass on MRI and/or CT that is not bidimensionally measurable but clearly evaluable for response to therapy): unequivocal increase in size of contrast enhancement or increase in mass effect as agreed upon independently by primary physician and quality control physicians: appearance of new lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
103 participants
Primary outcome timeframe
At 6 months
Results posted on
2014-05-23
Participant Flow
Participants were recruited from 24 medical clinics in the United States between September 2005 to May 2008.
Participant milestones
| Measure |
Stratum 1 (Not Undergoing Surgery)
Patients not receiving pre-surgery SAHA with ≤1 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.
|
Stratum 2 (Undergoing Surgery)
Beginning 3 days prior to surgery, patients receive oral vorinostat (SAHA) once or twice daily for a total of 6 doses. Patients then undergo surgery to remove the tumor. Beginning within 1-4 weeks after surgery, patients receive oral SAHA twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.
surgery : Patients undergo surgery to remove tumor
|
Stratum 3 (Not Undergoing Surgery)
Patients not receiving pre-surgery SAHA with ≥2 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.
|
|---|---|---|---|
|
Overall Study
STARTED
|
68
|
15
|
20
|
|
Overall Study
COMPLETED
|
53
|
13
|
11
|
|
Overall Study
NOT COMPLETED
|
15
|
2
|
9
|
Reasons for withdrawal
| Measure |
Stratum 1 (Not Undergoing Surgery)
Patients not receiving pre-surgery SAHA with ≤1 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.
|
Stratum 2 (Undergoing Surgery)
Beginning 3 days prior to surgery, patients receive oral vorinostat (SAHA) once or twice daily for a total of 6 doses. Patients then undergo surgery to remove the tumor. Beginning within 1-4 weeks after surgery, patients receive oral SAHA twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.
surgery : Patients undergo surgery to remove tumor
|
Stratum 3 (Not Undergoing Surgery)
Patients not receiving pre-surgery SAHA with ≥2 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
11
|
1
|
2
|
|
Overall Study
Death
|
1
|
0
|
1
|
|
Overall Study
Other Medical Problems
|
2
|
0
|
2
|
|
Overall Study
Poor tolerance of study treatment
|
1
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
1
|
3
|
Baseline Characteristics
Vorinostat in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme
Baseline characteristics by cohort
| Measure |
Stratum 1 (Not Undergoing Surgery)
n=68 Participants
Patients not receiving pre-surgery SAHA with ≤1 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.
|
Stratum 2 (Undergoing Surgery)
n=15 Participants
Beginning 3 days prior to surgery, patients receive oral vorinostat (SAHA) once or twice daily for a total of 6 doses. Patients then undergo surgery to remove the tumor. Beginning within 1-4 weeks after surgery, patients receive oral SAHA twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.
surgery : Patients undergo surgery to remove tumor
|
Stratum 3 (Not Undergoing Surgery)
n=20 Participants
Patients not receiving pre-surgery SAHA with ≥2 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.
|
Total
n=103 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
58 years
n=5 Participants
|
49 years
n=7 Participants
|
55.5 years
n=5 Participants
|
56 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
68 participants
n=5 Participants
|
15 participants
n=7 Participants
|
20 participants
n=5 Participants
|
103 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At 6 monthsPopulation: 68 Stratum 1 patients were enrolled. 2 stratum 1 patients did not receive treatment. Therefore, the remaining 66 patients were analyzed.
Estimated using the Binomial point estimator (number of successes divided by the total number of evaluable patients) and the Binomial 95% confidence interval estimated by the exact method. Definition of progression: Bidimensionally measurable disease: \>25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions. Evaluable disease (i.e., contrast enhancing mass on MRI and/or CT that is not bidimensionally measurable but clearly evaluable for response to therapy): unequivocal increase in size of contrast enhancement or increase in mass effect as agreed upon independently by primary physician and quality control physicians: appearance of new lesions.
Outcome measures
| Measure |
Stratum 1 Patients That Started Treatment
n=66 Participants
Patients not receiving pre-surgery SAHA with ≤1 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.
|
Stratum 2 (Undergoing Surgery)
n=15 Participants
Beginning 3 days prior to surgery, patients receive oral vorinostat (SAHA) once or twice daily for a total of 6 doses. Patients then undergo surgery to remove the tumor. Beginning within 1-4 weeks after surgery, patients receive oral SAHA twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.
surgery : Patients undergo surgery to remove tumor
|
Stratum 3 (Not Undergoing Surgery)
n=20 Participants
Patients not receiving pre-surgery SAHA with ≥2 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.
|
|---|---|---|---|
|
Proportion of Successes (Patients Alive and Progression-free)
|
15.2 percentage of participants
Interval 7.5 to 26.1
|
26.7 percentage of participants
Interval 7.8 to 55.1
|
10 percentage of participants
Interval 1.2 to 31.7
|
SECONDARY outcome
Timeframe: From study registration to date of death due to any cause or last follow-up (up to 5 years)Population: Stratum 1: 68 patients were enrolled. 2 patients did not receive treatment. Therefore, the remaining 66 patients were analyzed. The patient that survived 28 months was alive at last follow-up.
Estimated using Kaplan-Meier survival curve.
Outcome measures
| Measure |
Stratum 1 Patients That Started Treatment
n=66 Participants
Patients not receiving pre-surgery SAHA with ≤1 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.
|
Stratum 2 (Undergoing Surgery)
n=15 Participants
Beginning 3 days prior to surgery, patients receive oral vorinostat (SAHA) once or twice daily for a total of 6 doses. Patients then undergo surgery to remove the tumor. Beginning within 1-4 weeks after surgery, patients receive oral SAHA twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.
surgery : Patients undergo surgery to remove tumor
|
Stratum 3 (Not Undergoing Surgery)
n=20 Participants
Patients not receiving pre-surgery SAHA with ≥2 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.
|
|---|---|---|---|
|
Survival
|
5.7 months
Interval 0.7 to 28.0
|
10.2 months
Interval 2.8 to 41.6
|
2.2 months
Interval 0.26 to 42.3
|
SECONDARY outcome
Timeframe: Assessed up to 5 yearsPopulation: Stratum 1: 68 patients were enrolled. 2 patients did not receive treatment. Therefore, the remaining 66 patients were analyzed. Stratum 2: Since the patients underwent surgery, response is not applicable and hence 0 patients analyzed.
A confirmed tumor response will be defined as an objective status of complete response (CR), partial response (PR), or regression (REGR) on two consecutive evaluations, which include neuroimaging, lasting during a period of at least 6 weeks. Confidence intervals for the true proportion will be calculated using the exact binomial method. Bidimensionally measurable disease:≥50% reduction in product of perpendicular diameters of contrast enhancement or mass with no new lesions with the patient being on stable or decreased steroid dose. Evaluable disease (i.e., contrast enhancing mass on MRI and/or CT that is not bidimensionally measurable but clearly evaluable for response to therapy): unequivocal reduction in size of contrast-enhancement or decrease in mass effect as agreed upon independently by primary physician and quality control physicians; no new lesions. Patient should be on stable or decreased steroid dose.
Outcome measures
| Measure |
Stratum 1 Patients That Started Treatment
n=66 Participants
Patients not receiving pre-surgery SAHA with ≤1 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.
|
Stratum 2 (Undergoing Surgery)
Beginning 3 days prior to surgery, patients receive oral vorinostat (SAHA) once or twice daily for a total of 6 doses. Patients then undergo surgery to remove the tumor. Beginning within 1-4 weeks after surgery, patients receive oral SAHA twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.
surgery : Patients undergo surgery to remove tumor
|
Stratum 3 (Not Undergoing Surgery)
n=20 Participants
Patients not receiving pre-surgery SAHA with ≥2 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.
|
|---|---|---|---|
|
Confirmed Tumor Response
|
3.0 percentage of participants
Interval 0.4 to 10.5
|
—
|
0 percentage of participants
Interval 0.0 to 16.8
|
SECONDARY outcome
Timeframe: From registration to disease progression (up to 5 years)Population: Stratum 1: 68 patients were enrolled. 2 stratum 1 patients did not receive treatment. Therefore, the remaining 66 patients were analyzed. The patient that survived 28 months was progression-free at last follow-up.
Estimated using Kaplan-Meier survival curve. Definition of progression: Bidimensionally measurable disease: \>25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions. Evaluable disease (i.e., contrast enhancing mass on MRI and/or CT that is not bidimensionally measurable but clearly evaluable for response to therapy): unequivocal increase in size of contrast enhancement or increase in mass effect as agreed upon independently by primary physician and quality control physicians: appearance of new lesions.
Outcome measures
| Measure |
Stratum 1 Patients That Started Treatment
n=66 Participants
Patients not receiving pre-surgery SAHA with ≤1 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.
|
Stratum 2 (Undergoing Surgery)
n=15 Participants
Beginning 3 days prior to surgery, patients receive oral vorinostat (SAHA) once or twice daily for a total of 6 doses. Patients then undergo surgery to remove the tumor. Beginning within 1-4 weeks after surgery, patients receive oral SAHA twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.
surgery : Patients undergo surgery to remove tumor
|
Stratum 3 (Not Undergoing Surgery)
n=20 Participants
Patients not receiving pre-surgery SAHA with ≥2 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.
|
|---|---|---|---|
|
Time to Progression
|
1.9 months
Interval 0.3 to 28.0
|
3.7 months
Interval 1.4 to 41.6
|
1.4 months
Interval 0.2 to 42.3
|
Adverse Events
Stratum 1 (Not Undergoing Surgery)
Serious events: 13 serious events
Other events: 65 other events
Deaths: 0 deaths
Stratum 2 (Undergoing Surgery)
Serious events: 3 serious events
Other events: 14 other events
Deaths: 0 deaths
Stratum 3 (Not Undergoing Surgery)
Serious events: 4 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Stratum 1 (Not Undergoing Surgery)
n=66 participants at risk
vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.
|
Stratum 2 (Undergoing Surgery)
n=15 participants at risk
surgery : Patients undergo surgery to remove tumor
|
Stratum 3 (Not Undergoing Surgery)
n=20 participants at risk
vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.
|
|---|---|---|---|
|
Cardiac disorders
Arrhythmia supraventricular
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
0.00%
0/20
|
|
Gastrointestinal disorders
Abdominal pain
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
0.00%
0/20
|
|
Gastrointestinal disorders
Diarrhea
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
0.00%
0/20
|
|
Gastrointestinal disorders
Dysphagia
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
0.00%
0/20
|
|
Gastrointestinal disorders
Nausea
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
0.00%
0/20
|
|
Gastrointestinal disorders
Vomiting
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
0.00%
0/20
|
|
General disorders
Disease progression
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
5.0%
1/20 • Number of events 1
|
|
General disorders
Fatigue
|
3.0%
2/66 • Number of events 2
|
0.00%
0/15
|
0.00%
0/20
|
|
Infections and infestations
Bladder infection
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
0.00%
0/20
|
|
Infections and infestations
Bronchitis
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
0.00%
0/20
|
|
Infections and infestations
Mucosal infection
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
0.00%
0/20
|
|
Infections and infestations
Pneumonia
|
4.5%
3/66 • Number of events 3
|
0.00%
0/15
|
0.00%
0/20
|
|
Investigations
Alanine aminotransferase increased
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
0.00%
0/20
|
|
Investigations
Amylase increased
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
0.00%
0/20
|
|
Investigations
Leukocyte count decreased
|
3.0%
2/66 • Number of events 2
|
0.00%
0/15
|
0.00%
0/20
|
|
Investigations
Lipase increased
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
0.00%
0/20
|
|
Investigations
Neutrophil count decreased
|
4.5%
3/66 • Number of events 3
|
0.00%
0/15
|
0.00%
0/20
|
|
Investigations
Platelet count decreased
|
10.6%
7/66 • Number of events 7
|
0.00%
0/15
|
5.0%
1/20 • Number of events 1
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
0.00%
0/20
|
|
Metabolism and nutrition disorders
Dehydration
|
3.0%
2/66 • Number of events 3
|
0.00%
0/15
|
0.00%
0/20
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
0.00%
0/20
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
0.00%
0/20
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
3.0%
2/66 • Number of events 2
|
0.00%
0/15
|
0.00%
0/20
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
0.00%
0/20
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
0.00%
0/66
|
0.00%
0/15
|
5.0%
1/20 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
0.00%
0/20
|
|
Nervous system disorders
Central nervous system necrosis
|
0.00%
0/66
|
6.7%
1/15 • Number of events 1
|
0.00%
0/20
|
|
Nervous system disorders
Cognitive disturbance
|
3.0%
2/66 • Number of events 2
|
0.00%
0/15
|
0.00%
0/20
|
|
Nervous system disorders
Depressed level of consciousness
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
0.00%
0/20
|
|
Nervous system disorders
Dizziness
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
5.0%
1/20 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.00%
0/66
|
13.3%
2/15 • Number of events 2
|
0.00%
0/20
|
|
Nervous system disorders
Hydrocephalus
|
1.5%
1/66 • Number of events 1
|
6.7%
1/15 • Number of events 1
|
0.00%
0/20
|
|
Nervous system disorders
Intracranial hemorrhage
|
3.0%
2/66 • Number of events 2
|
0.00%
0/15
|
0.00%
0/20
|
|
Nervous system disorders
Peripheral motor neuropathy
|
3.0%
2/66 • Number of events 2
|
0.00%
0/15
|
5.0%
1/20 • Number of events 1
|
|
Nervous system disorders
Seizure
|
3.0%
2/66 • Number of events 2
|
0.00%
0/15
|
5.0%
1/20 • Number of events 1
|
|
Nervous system disorders
Speech disorder
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
5.0%
1/20 • Number of events 1
|
|
Nervous system disorders
Syncope
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
0.00%
0/20
|
|
Psychiatric disorders
Anxiety
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
0.00%
0/20
|
|
Psychiatric disorders
Confusion
|
4.5%
3/66 • Number of events 3
|
0.00%
0/15
|
0.00%
0/20
|
|
Renal and urinary disorders
Renal failure
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
0.00%
0/20
|
|
Vascular disorders
Hypertension
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
5.0%
1/20 • Number of events 1
|
|
Vascular disorders
Hypotension
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
0.00%
0/20
|
|
Vascular disorders
Thrombosis
|
4.5%
3/66 • Number of events 3
|
0.00%
0/15
|
0.00%
0/20
|
Other adverse events
| Measure |
Stratum 1 (Not Undergoing Surgery)
n=66 participants at risk
vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.
|
Stratum 2 (Undergoing Surgery)
n=15 participants at risk
surgery : Patients undergo surgery to remove tumor
|
Stratum 3 (Not Undergoing Surgery)
n=20 participants at risk
vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
51.5%
34/66 • Number of events 156
|
66.7%
10/15 • Number of events 47
|
45.0%
9/20 • Number of events 57
|
|
Eye disorders
Diplopia
|
0.00%
0/66
|
6.7%
1/15 • Number of events 1
|
0.00%
0/20
|
|
Eye disorders
Vision blurred
|
3.0%
2/66 • Number of events 2
|
0.00%
0/15
|
0.00%
0/20
|
|
Eye disorders
Vitreous hemorrhage
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
0.00%
0/20
|
|
Gastrointestinal disorders
Abdominal pain
|
18.2%
12/66 • Number of events 41
|
20.0%
3/15 • Number of events 4
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
6.1%
4/66 • Number of events 10
|
6.7%
1/15 • Number of events 11
|
10.0%
2/20 • Number of events 5
|
|
Gastrointestinal disorders
Diarrhea
|
31.8%
21/66 • Number of events 63
|
46.7%
7/15 • Number of events 27
|
40.0%
8/20 • Number of events 12
|
|
Gastrointestinal disorders
Dry mouth
|
3.0%
2/66 • Number of events 6
|
0.00%
0/15
|
0.00%
0/20
|
|
Gastrointestinal disorders
Dyspepsia
|
3.0%
2/66 • Number of events 3
|
0.00%
0/15
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
0.00%
0/20
|
|
Gastrointestinal disorders
Esophageal mucositis
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
0.00%
0/20
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/66
|
0.00%
0/15
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Flatulence
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
0.00%
0/20
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/66
|
0.00%
0/15
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis oral
|
4.5%
3/66 • Number of events 4
|
0.00%
0/15
|
0.00%
0/20
|
|
Gastrointestinal disorders
Nausea
|
25.8%
17/66 • Number of events 52
|
53.3%
8/15 • Number of events 13
|
35.0%
7/20 • Number of events 15
|
|
Gastrointestinal disorders
Oral hemorrhage
|
0.00%
0/66
|
0.00%
0/15
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
12.1%
8/66 • Number of events 14
|
26.7%
4/15 • Number of events 5
|
15.0%
3/20 • Number of events 4
|
|
General disorders
Chills
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
0.00%
0/20
|
|
General disorders
Edema limbs
|
4.5%
3/66 • Number of events 4
|
6.7%
1/15 • Number of events 2
|
0.00%
0/20
|
|
General disorders
Fatigue
|
86.4%
57/66 • Number of events 192
|
73.3%
11/15 • Number of events 72
|
80.0%
16/20 • Number of events 46
|
|
General disorders
Fever
|
3.0%
2/66 • Number of events 3
|
6.7%
1/15 • Number of events 3
|
0.00%
0/20
|
|
General disorders
Gait abnormal
|
3.0%
2/66 • Number of events 2
|
0.00%
0/15
|
0.00%
0/20
|
|
General disorders
Localized edema
|
3.0%
2/66 • Number of events 3
|
0.00%
0/15
|
0.00%
0/20
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/66
|
0.00%
0/15
|
5.0%
1/20 • Number of events 1
|
|
Infections and infestations
Bladder infection
|
3.0%
2/66 • Number of events 2
|
0.00%
0/15
|
0.00%
0/20
|
|
Infections and infestations
Gingival infection
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
0.00%
0/20
|
|
Infections and infestations
Infection
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
0.00%
0/20
|
|
Infections and infestations
Penile infection
|
0.00%
0/66
|
0.00%
0/15
|
5.0%
1/20 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
3.0%
2/66 • Number of events 2
|
0.00%
0/15
|
0.00%
0/20
|
|
Infections and infestations
Sepsis
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
0.00%
0/20
|
|
Infections and infestations
Sinusitis
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
0.00%
0/20
|
|
Infections and infestations
Upper respiratory infection
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
0.00%
0/20
|
|
Infections and infestations
Vaginal infection
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
0.00%
0/20
|
|
Injury, poisoning and procedural complications
Arterial injury - Extremity-lower
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
0.00%
0/20
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
0.00%
0/20
|
|
Investigations
Alanine aminotransferase increased
|
6.1%
4/66 • Number of events 11
|
13.3%
2/15 • Number of events 3
|
15.0%
3/20 • Number of events 8
|
|
Investigations
Alkaline phosphatase increased
|
10.6%
7/66 • Number of events 42
|
6.7%
1/15 • Number of events 1
|
10.0%
2/20 • Number of events 6
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
11/66 • Number of events 19
|
13.3%
2/15 • Number of events 2
|
15.0%
3/20 • Number of events 8
|
|
Investigations
Blood bilirubin increased
|
1.5%
1/66 • Number of events 1
|
20.0%
3/15 • Number of events 3
|
5.0%
1/20 • Number of events 1
|
|
Investigations
CD4 lymphocytes decreased
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
0.00%
0/20
|
|
Investigations
Creatine phosphokinase increased
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
0.00%
0/20
|
|
Investigations
Creatinine increased
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
5.0%
1/20 • Number of events 8
|
|
Investigations
Laboratory test abnormal
|
1.5%
1/66 • Number of events 4
|
0.00%
0/15
|
5.0%
1/20 • Number of events 1
|
|
Investigations
Leukocyte count decreased
|
39.4%
26/66 • Number of events 109
|
60.0%
9/15 • Number of events 32
|
25.0%
5/20 • Number of events 31
|
|
Investigations
Lymphocyte count decreased
|
7.6%
5/66 • Number of events 21
|
0.00%
0/15
|
10.0%
2/20 • Number of events 2
|
|
Investigations
Neutrophil count decreased
|
30.3%
20/66 • Number of events 87
|
40.0%
6/15 • Number of events 19
|
25.0%
5/20 • Number of events 16
|
|
Investigations
Platelet count decreased
|
68.2%
45/66 • Number of events 198
|
80.0%
12/15 • Number of events 33
|
85.0%
17/20 • Number of events 55
|
|
Investigations
Serum cholesterol increased
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
5.0%
1/20 • Number of events 1
|
|
Investigations
Weight gain
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
0.00%
0/20
|
|
Investigations
Weight loss
|
3.0%
2/66 • Number of events 2
|
6.7%
1/15 • Number of events 1
|
15.0%
3/20 • Number of events 9
|
|
Metabolism and nutrition disorders
Acidosis
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
0.00%
0/20
|
|
Metabolism and nutrition disorders
Alkalosis
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
0.00%
0/20
|
|
Metabolism and nutrition disorders
Anorexia
|
27.3%
18/66 • Number of events 43
|
33.3%
5/15 • Number of events 22
|
50.0%
10/20 • Number of events 18
|
|
Metabolism and nutrition disorders
Blood bicarbonate decreased
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
0.00%
0/20
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
33.3%
22/66 • Number of events 37
|
6.7%
1/15 • Number of events 1
|
15.0%
3/20 • Number of events 37
|
|
Metabolism and nutrition disorders
Dehydration
|
9.1%
6/66 • Number of events 10
|
13.3%
2/15 • Number of events 2
|
5.0%
1/20 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
6.1%
4/66 • Number of events 6
|
0.00%
0/15
|
5.0%
1/20 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
6.1%
4/66 • Number of events 7
|
6.7%
1/15 • Number of events 1
|
5.0%
1/20 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum calcium increased
|
0.00%
0/66
|
0.00%
0/15
|
5.0%
1/20 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
0.00%
0/20
|
|
Metabolism and nutrition disorders
Serum magnesium increased
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
0.00%
0/20
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
1.5%
1/66 • Number of events 2
|
0.00%
0/15
|
0.00%
0/20
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
0.00%
0/20
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
5.0%
1/20 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
4.5%
3/66 • Number of events 3
|
0.00%
0/15
|
10.0%
2/20 • Number of events 7
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
3.0%
2/66 • Number of events 3
|
0.00%
0/15
|
0.00%
0/20
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
5.0%
1/20 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.5%
1/66 • Number of events 2
|
0.00%
0/15
|
0.00%
0/20
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
10.6%
7/66 • Number of events 7
|
0.00%
0/15
|
15.0%
3/20 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
5.0%
1/20 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
4.5%
3/66 • Number of events 3
|
0.00%
0/15
|
5.0%
1/20 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
3.0%
2/66 • Number of events 2
|
0.00%
0/15
|
0.00%
0/20
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
0.00%
0/20
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.0%
2/66 • Number of events 2
|
0.00%
0/15
|
5.0%
1/20 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
0.00%
0/20
|
|
Nervous system disorders
Accessory nerve disorder
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
0.00%
0/20
|
|
Nervous system disorders
Ataxia
|
10.6%
7/66 • Number of events 9
|
0.00%
0/15
|
5.0%
1/20 • Number of events 2
|
|
Nervous system disorders
Cognitive disturbance
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
5.0%
1/20 • Number of events 4
|
|
Nervous system disorders
Depressed level of consciousness
|
4.5%
3/66 • Number of events 3
|
0.00%
0/15
|
10.0%
2/20 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
7.6%
5/66 • Number of events 5
|
6.7%
1/15 • Number of events 1
|
0.00%
0/20
|
|
Nervous system disorders
Dysgeusia
|
22.7%
15/66 • Number of events 51
|
20.0%
3/15 • Number of events 14
|
20.0%
4/20 • Number of events 6
|
|
Nervous system disorders
Extrapyramidal disorder
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
0.00%
0/20
|
|
Nervous system disorders
Headache
|
18.2%
12/66 • Number of events 21
|
20.0%
3/15 • Number of events 3
|
10.0%
2/20 • Number of events 3
|
|
Nervous system disorders
Ischemia cerebrovascular
|
0.00%
0/66
|
6.7%
1/15 • Number of events 1
|
0.00%
0/20
|
|
Nervous system disorders
Memory impairment
|
3.0%
2/66 • Number of events 2
|
0.00%
0/15
|
5.0%
1/20 • Number of events 4
|
|
Nervous system disorders
Neurological disorder NOS
|
1.5%
1/66 • Number of events 2
|
0.00%
0/15
|
0.00%
0/20
|
|
Nervous system disorders
Peripheral motor neuropathy
|
1.5%
1/66 • Number of events 2
|
0.00%
0/15
|
5.0%
1/20 • Number of events 34
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
5.0%
1/20 • Number of events 11
|
|
Nervous system disorders
Seizure
|
3.0%
2/66 • Number of events 2
|
0.00%
0/15
|
10.0%
2/20 • Number of events 2
|
|
Nervous system disorders
Sinus pain
|
0.00%
0/66
|
6.7%
1/15 • Number of events 6
|
0.00%
0/20
|
|
Nervous system disorders
Speech disorder
|
10.6%
7/66 • Number of events 7
|
0.00%
0/15
|
5.0%
1/20 • Number of events 19
|
|
Nervous system disorders
Syncope
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
0.00%
0/20
|
|
Psychiatric disorders
Anxiety
|
3.0%
2/66 • Number of events 2
|
0.00%
0/15
|
0.00%
0/20
|
|
Psychiatric disorders
Confusion
|
4.5%
3/66 • Number of events 4
|
0.00%
0/15
|
5.0%
1/20 • Number of events 1
|
|
Psychiatric disorders
Depression
|
3.0%
2/66 • Number of events 4
|
0.00%
0/15
|
0.00%
0/20
|
|
Psychiatric disorders
Insomnia
|
1.5%
1/66 • Number of events 4
|
6.7%
1/15 • Number of events 9
|
5.0%
1/20 • Number of events 1
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/66
|
0.00%
0/15
|
5.0%
1/20 • Number of events 1
|
|
Renal and urinary disorders
Hemorrhage urinary tract
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
0.00%
0/20
|
|
Renal and urinary disorders
Urinary frequency
|
3.0%
2/66 • Number of events 2
|
0.00%
0/15
|
0.00%
0/20
|
|
Renal and urinary disorders
Urogenital disorder
|
3.0%
2/66 • Number of events 3
|
0.00%
0/15
|
5.0%
1/20 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/66
|
0.00%
0/15
|
5.0%
1/20 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.5%
1/66 • Number of events 1
|
6.7%
1/15 • Number of events 2
|
10.0%
2/20 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.5%
3/66 • Number of events 3
|
0.00%
0/15
|
5.0%
1/20 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
3.0%
2/66 • Number of events 2
|
0.00%
0/15
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal mucositis
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.0%
2/66 • Number of events 7
|
0.00%
0/15
|
5.0%
1/20 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.0%
2/66 • Number of events 21
|
6.7%
1/15 • Number of events 7
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
3.0%
2/66 • Number of events 3
|
0.00%
0/15
|
0.00%
0/20
|
|
Vascular disorders
Hemorrhage
|
0.00%
0/66
|
6.7%
1/15 • Number of events 1
|
0.00%
0/20
|
|
Vascular disorders
Hypertension
|
1.5%
1/66 • Number of events 1
|
0.00%
0/15
|
0.00%
0/20
|
|
Vascular disorders
Hypotension
|
3.0%
2/66 • Number of events 2
|
0.00%
0/15
|
5.0%
1/20 • Number of events 1
|
|
Vascular disorders
Thrombosis
|
4.5%
3/66 • Number of events 3
|
0.00%
0/15
|
5.0%
1/20 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60