Trial Outcomes & Findings for Pegfilgrastim and Rituximab in Treating Patients With Untreated, Relapsed, or Refractory Follicular Lymphoma, Small Lymphocytic Lymphoma, or Marginal Zone Lymphoma (NCT NCT01682044)
NCT ID: NCT01682044
Last Updated: 2017-10-09
Results Overview
Frequency of Adverse Events, Graded According to NCI CTCAE v3.0. Grade 1: Mild AE; Grade 2: Moderate AE; Grade 3: Severe AE; Grade 4: Life-threatening or disabling AE; Grade 5: Death related to AE
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
Up to 90 days after the last dose of study drugs
Results posted on
2017-10-09
Participant Flow
Participant milestones
| Measure |
Treatment (Colony-stimulating Factor and Monoclonal Antibody)
Patients receive pegfilgrastim SC followed by rituximab IV 3 days later in weeks 1, 3, 5, 7, 15, 23, 31, and 39. Treatment continues in the absence of disease progression or unacceptable toxicity.
pegfilgrastim: Given SC
rituximab: Given IV
flow cytometry: Correlative studies
biopsy: Correlative studies
immunohistochemistry staining method: Correlative studies
western blotting: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Treatment (Colony-stimulating Factor and Monoclonal Antibody)
Patients receive pegfilgrastim SC followed by rituximab IV 3 days later in weeks 1, 3, 5, 7, 15, 23, 31, and 39. Treatment continues in the absence of disease progression or unacceptable toxicity.
pegfilgrastim: Given SC
rituximab: Given IV
flow cytometry: Correlative studies
biopsy: Correlative studies
immunohistochemistry staining method: Correlative studies
western blotting: Correlative studies
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Progression
|
3
|
Baseline Characteristics
Pegfilgrastim and Rituximab in Treating Patients With Untreated, Relapsed, or Refractory Follicular Lymphoma, Small Lymphocytic Lymphoma, or Marginal Zone Lymphoma
Baseline characteristics by cohort
| Measure |
Treatment (Colony-stimulating Factor and Monoclonal Antibody)
n=20 Participants
Patients receive pegfilgrastim SC followed by rituximab IV 3 days later in weeks 1, 3, 5, 7, 15, 23, 31, and 39. Treatment continues in the absence of disease progression or unacceptable toxicity.
pegfilgrastim: Given SC
rituximab: Given IV
flow cytometry: Correlative studies
biopsy: Correlative studies
immunohistochemistry staining method: Correlative studies
western blotting: Correlative studies
|
|---|---|
|
Age, Continuous
|
60.9 years
STANDARD_DEVIATION 13.1 • n=93 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Up to 90 days after the last dose of study drugsPopulation: All treated and eligible patients
Frequency of Adverse Events, Graded According to NCI CTCAE v3.0. Grade 1: Mild AE; Grade 2: Moderate AE; Grade 3: Severe AE; Grade 4: Life-threatening or disabling AE; Grade 5: Death related to AE
Outcome measures
| Measure |
Treatment (Colony-stimulating Factor and Monoclonal Antibody)
n=20 Participants
Patients receive pegfilgrastim SC followed by rituximab IV 3 days later in weeks 1, 3, 5, 7, 15, 23, 31, and 39. Treatment continues in the absence of disease progression or unacceptable toxicity.
pegfilgrastim: Given SC
rituximab: Given IV
flow cytometry: Correlative studies
biopsy: Correlative studies
immunohistochemistry staining method: Correlative studies
western blotting: Correlative studies
|
|---|---|
|
Number of Participants With Adverse Events
Grade 1
|
3 Participants
|
|
Number of Participants With Adverse Events
Grade 2
|
9 Participants
|
|
Number of Participants With Adverse Events
Grade 5
|
1 Participants
|
|
Number of Participants With Adverse Events
Grade 3
|
6 Participants
|
|
Number of Participants With Adverse Events
Grade 4
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 43 weeksPopulation: All treated and eligible patients
Overall Response is defined as Complete Response: During observation, no disease is apparent, including measurable and non-measurable disease, and no evidence of disease is observed for at least 28 days, as confirmed by a second assessment following the original observation of no disease; and Partial Response: A 50% or greater decrease from baseline in the sum of the products of the longest perpendicular diameters of all the measured lesions is noted for at least 28 days as confirmed by a second assessment following the observation of the 50% or greater decrease, and no appearance of new lesions is noted.
Outcome measures
| Measure |
Treatment (Colony-stimulating Factor and Monoclonal Antibody)
n=20 Participants
Patients receive pegfilgrastim SC followed by rituximab IV 3 days later in weeks 1, 3, 5, 7, 15, 23, 31, and 39. Treatment continues in the absence of disease progression or unacceptable toxicity.
pegfilgrastim: Given SC
rituximab: Given IV
flow cytometry: Correlative studies
biopsy: Correlative studies
immunohistochemistry staining method: Correlative studies
western blotting: Correlative studies
|
|---|---|
|
Overall Response Rate
|
60 percentage of participants
Interval 38.7 to 78.1
|
SECONDARY outcome
Timeframe: Baseline and weeks 1, 3, 5, 7, 15, 23, 31, and 39Population: All treated and eligible patients
Mean percent change in CD11b level from baseline at each visit
Outcome measures
| Measure |
Treatment (Colony-stimulating Factor and Monoclonal Antibody)
n=20 Participants
Patients receive pegfilgrastim SC followed by rituximab IV 3 days later in weeks 1, 3, 5, 7, 15, 23, 31, and 39. Treatment continues in the absence of disease progression or unacceptable toxicity.
pegfilgrastim: Given SC
rituximab: Given IV
flow cytometry: Correlative studies
biopsy: Correlative studies
immunohistochemistry staining method: Correlative studies
western blotting: Correlative studies
|
|---|---|
|
Percent Change in Functional and Phenotypic Characteristics of Host Neutrophils From Baseline
week 1
|
-20.2 percent change
Standard Deviation 34.0
|
|
Percent Change in Functional and Phenotypic Characteristics of Host Neutrophils From Baseline
week 3
|
-35.5 percent change
Standard Deviation 28.3
|
|
Percent Change in Functional and Phenotypic Characteristics of Host Neutrophils From Baseline
week 5
|
-24.7 percent change
Standard Deviation 117.7
|
|
Percent Change in Functional and Phenotypic Characteristics of Host Neutrophils From Baseline
week 7
|
-56.8 percent change
Standard Deviation 27.4
|
|
Percent Change in Functional and Phenotypic Characteristics of Host Neutrophils From Baseline
week 15
|
-23.8 percent change
Standard Deviation 40.1
|
|
Percent Change in Functional and Phenotypic Characteristics of Host Neutrophils From Baseline
week 23
|
-19.7 percent change
Standard Deviation 35.7
|
|
Percent Change in Functional and Phenotypic Characteristics of Host Neutrophils From Baseline
week 31
|
-18.7 percent change
Standard Deviation 47.0
|
|
Percent Change in Functional and Phenotypic Characteristics of Host Neutrophils From Baseline
week 39
|
-10.1 percent change
Standard Deviation 42.7
|
SECONDARY outcome
Timeframe: At 4 yearsPopulation: Samples tissues were not large enough to perform analysis. No participants were analyze.
Percent change in CD20 antigen expression and density of expression
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and weeks 1, 3, 5, 7, 15, 23, 31, and 39Population: All treated and eligible patients
Mean percent change in TNF level from baseline at each visit.
Outcome measures
| Measure |
Treatment (Colony-stimulating Factor and Monoclonal Antibody)
n=20 Participants
Patients receive pegfilgrastim SC followed by rituximab IV 3 days later in weeks 1, 3, 5, 7, 15, 23, 31, and 39. Treatment continues in the absence of disease progression or unacceptable toxicity.
pegfilgrastim: Given SC
rituximab: Given IV
flow cytometry: Correlative studies
biopsy: Correlative studies
immunohistochemistry staining method: Correlative studies
western blotting: Correlative studies
|
|---|---|
|
Percent Change in Serum Levels of Tumor Necrosis Factor (TNF) From Baseline
week 1
|
51.5 percent change
Standard Deviation 65.1
|
|
Percent Change in Serum Levels of Tumor Necrosis Factor (TNF) From Baseline
week 3
|
14.5 percent change
Standard Deviation 47.7
|
|
Percent Change in Serum Levels of Tumor Necrosis Factor (TNF) From Baseline
week 5
|
11.2 percent change
Standard Deviation 50.1
|
|
Percent Change in Serum Levels of Tumor Necrosis Factor (TNF) From Baseline
week 7
|
8.3 percent change
Standard Deviation 34.2
|
|
Percent Change in Serum Levels of Tumor Necrosis Factor (TNF) From Baseline
week 15
|
42.7 percent change
Standard Deviation 76.4
|
|
Percent Change in Serum Levels of Tumor Necrosis Factor (TNF) From Baseline
week 23
|
27.2 percent change
Standard Deviation 80.6
|
|
Percent Change in Serum Levels of Tumor Necrosis Factor (TNF) From Baseline
week 31
|
45.6 percent change
Standard Deviation 100.5
|
|
Percent Change in Serum Levels of Tumor Necrosis Factor (TNF) From Baseline
week 39
|
50.2 percent change
Standard Deviation 110.6
|
SECONDARY outcome
Timeframe: Baseline and weeks 1, 3, 5, 7, 15, 23, 31, and 39Population: All treated and eligible patients
Mean percent change in INF level from baseline.
Outcome measures
| Measure |
Treatment (Colony-stimulating Factor and Monoclonal Antibody)
n=20 Participants
Patients receive pegfilgrastim SC followed by rituximab IV 3 days later in weeks 1, 3, 5, 7, 15, 23, 31, and 39. Treatment continues in the absence of disease progression or unacceptable toxicity.
pegfilgrastim: Given SC
rituximab: Given IV
flow cytometry: Correlative studies
biopsy: Correlative studies
immunohistochemistry staining method: Correlative studies
western blotting: Correlative studies
|
|---|---|
|
Percent Change in Serum Levels of Interferon Alpha (INF) From Baseline
week 1
|
-18.8 percent change
Standard Deviation 33.2
|
|
Percent Change in Serum Levels of Interferon Alpha (INF) From Baseline
week 3
|
-27.8 percent change
Standard Deviation 42.9
|
|
Percent Change in Serum Levels of Interferon Alpha (INF) From Baseline
week 5
|
48.1 percent change
Standard Deviation 124.6
|
|
Percent Change in Serum Levels of Interferon Alpha (INF) From Baseline
week 7
|
8.0 percent change
Standard Deviation 71.4
|
|
Percent Change in Serum Levels of Interferon Alpha (INF) From Baseline
week 15
|
1.5 percent change
Standard Deviation 78.6
|
|
Percent Change in Serum Levels of Interferon Alpha (INF) From Baseline
week 23
|
-14.1 percent change
Standard Deviation 43.9
|
|
Percent Change in Serum Levels of Interferon Alpha (INF) From Baseline
week 31
|
-33.0 percent change
Standard Deviation 49.5
|
|
Percent Change in Serum Levels of Interferon Alpha (INF) From Baseline
week 39
|
-7.5 percent change
Standard Deviation 45.1
|
SECONDARY outcome
Timeframe: Baseline and weeks 1, 3, 5, 7, 15, 23, 31, and 39Population: All treated and eligible patients
Mean percent change in MFI level from baseline.
Outcome measures
| Measure |
Treatment (Colony-stimulating Factor and Monoclonal Antibody)
n=20 Participants
Patients receive pegfilgrastim SC followed by rituximab IV 3 days later in weeks 1, 3, 5, 7, 15, 23, 31, and 39. Treatment continues in the absence of disease progression or unacceptable toxicity.
pegfilgrastim: Given SC
rituximab: Given IV
flow cytometry: Correlative studies
biopsy: Correlative studies
immunohistochemistry staining method: Correlative studies
western blotting: Correlative studies
|
|---|---|
|
Percent Change in Serum Levels of Free Radical Levels (MFI) From Baseline
week 39
|
16.0 percent change
Standard Deviation 285.6
|
|
Percent Change in Serum Levels of Free Radical Levels (MFI) From Baseline
week 1
|
-32.0 percent change
Standard Deviation 66.8
|
|
Percent Change in Serum Levels of Free Radical Levels (MFI) From Baseline
week 3
|
-22.4 percent change
Standard Deviation 71.0
|
|
Percent Change in Serum Levels of Free Radical Levels (MFI) From Baseline
week 5
|
-45.4 percent change
Standard Deviation 66.5
|
|
Percent Change in Serum Levels of Free Radical Levels (MFI) From Baseline
week 7
|
-20.4 percent change
Standard Deviation 89.9
|
|
Percent Change in Serum Levels of Free Radical Levels (MFI) From Baseline
week 15
|
-5.8 percent change
Standard Deviation 137.6
|
|
Percent Change in Serum Levels of Free Radical Levels (MFI) From Baseline
week 23
|
0.4 percent change
Standard Deviation 219.1
|
|
Percent Change in Serum Levels of Free Radical Levels (MFI) From Baseline
week 31
|
295.8 percent change
Standard Deviation 996.1
|
Adverse Events
Treatment (Colony-stimulating Factor and Monoclonal Antibody)
Serious events: 2 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Colony-stimulating Factor and Monoclonal Antibody)
n=20 participants at risk
Patients receive pegfilgrastim SC followed by rituximab IV 3 days later in weeks 1, 3, 5, 7, 15, 23, 31, and 39. Treatment continues in the absence of disease progression or unacceptable toxicity.
pegfilgrastim: Given SC
rituximab: Given IV
flow cytometry: Correlative studies
biopsy: Correlative studies
immunohistochemistry staining method: Correlative studies
western blotting: Correlative studies
|
|---|---|
|
Cardiac disorders
Coronary artery occlusion
|
5.0%
1/20 • Number of events 1
|
|
Cardiac disorders
Sinus tachycardia
|
5.0%
1/20 • Number of events 1
|
|
Cardiac disorders
Ventricular arrhythmia
|
5.0%
1/20 • Number of events 1
|
|
Ear and labyrinth disorders
Vertigo
|
5.0%
1/20 • Number of events 1
|
|
General disorders
Death
|
5.0%
1/20 • Number of events 1
|
Other adverse events
| Measure |
Treatment (Colony-stimulating Factor and Monoclonal Antibody)
n=20 participants at risk
Patients receive pegfilgrastim SC followed by rituximab IV 3 days later in weeks 1, 3, 5, 7, 15, 23, 31, and 39. Treatment continues in the absence of disease progression or unacceptable toxicity.
pegfilgrastim: Given SC
rituximab: Given IV
flow cytometry: Correlative studies
biopsy: Correlative studies
immunohistochemistry staining method: Correlative studies
western blotting: Correlative studies
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
55.0%
11/20 • Number of events 15
|
|
Blood and lymphatic system disorders
Leukopenia
|
20.0%
4/20 • Number of events 11
|
|
Blood and lymphatic system disorders
Lymphopenia
|
40.0%
8/20 • Number of events 25
|
|
Blood and lymphatic system disorders
Neutropenia
|
10.0%
2/20 • Number of events 5
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
35.0%
7/20 • Number of events 14
|
|
Cardiac disorders
Supraventricular extrasystoles
|
5.0%
1/20 • Number of events 1
|
|
Cardiac disorders
Tachycardia
|
5.0%
1/20 • Number of events 1
|
|
Ear and labyrinth disorders
Ear discomfort
|
5.0%
1/20 • Number of events 1
|
|
Eye disorders
Diplopia
|
5.0%
1/20 • Number of events 1
|
|
Eye disorders
Lacrimation increased
|
5.0%
1/20 • Number of events 1
|
|
Eye disorders
Vitreous floaters
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal discomfort
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
2/20 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
10.0%
2/20 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
2/20 • Number of events 3
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Hiatus hernia
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Intestinal mass
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
35.0%
7/20 • Number of events 10
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
4/20 • Number of events 5
|
|
General disorders
Asthenia
|
10.0%
2/20 • Number of events 2
|
|
General disorders
Chills
|
30.0%
6/20 • Number of events 8
|
|
General disorders
Discomfort
|
5.0%
1/20 • Number of events 1
|
|
General disorders
Fatigue
|
20.0%
4/20 • Number of events 6
|
|
General disorders
Infusion site pain
|
5.0%
1/20 • Number of events 1
|
|
General disorders
Malaise
|
5.0%
1/20 • Number of events 1
|
|
General disorders
Oedema peripheral
|
5.0%
1/20 • Number of events 1
|
|
General disorders
Pain
|
20.0%
4/20 • Number of events 4
|
|
General disorders
Pyrexia
|
10.0%
2/20 • Number of events 2
|
|
General disorders
Sensation of foreign body
|
5.0%
1/20 • Number of events 1
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
5.0%
1/20 • Number of events 1
|
|
Immune system disorders
Cytokine release syndrome
|
30.0%
6/20 • Number of events 6
|
|
Infections and infestations
Cellulitis
|
5.0%
1/20 • Number of events 1
|
|
Infections and infestations
Influenza
|
5.0%
1/20 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
5.0%
1/20 • Number of events 1
|
|
Infections and infestations
Respiratory tract infection
|
15.0%
3/20 • Number of events 3
|
|
Infections and infestations
Sinusitis
|
5.0%
1/20 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
5.0%
1/20 • Number of events 1
|
|
Injury, poisoning and procedural complications
Procedural pain
|
5.0%
1/20 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
5.0%
1/20 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
15.0%
3/20 • Number of events 4
|
|
Investigations
Blood albumin
|
5.0%
1/20 • Number of events 1
|
|
Investigations
Blood alkaline phosphatase
|
75.0%
15/20 • Number of events 52
|
|
Investigations
Blood alkaline phosphatase increased
|
15.0%
3/20 • Number of events 5
|
|
Investigations
Blood creatine
|
5.0%
1/20 • Number of events 1
|
|
Investigations
Blood creatinine
|
10.0%
2/20 • Number of events 2
|
|
Investigations
Blood creatinine increased
|
5.0%
1/20 • Number of events 3
|
|
Investigations
Blood glucose
|
5.0%
1/20 • Number of events 1
|
|
Investigations
Blood glucose decreased
|
5.0%
1/20 • Number of events 2
|
|
Investigations
Blood potassium decreased
|
5.0%
1/20 • Number of events 2
|
|
Investigations
Blood sodium
|
10.0%
2/20 • Number of events 2
|
|
Investigations
Blood sodium decreased
|
5.0%
1/20 • Number of events 1
|
|
Investigations
Blood sodium increased
|
5.0%
1/20 • Number of events 1
|
|
Investigations
Blood uric acid increased
|
20.0%
4/20 • Number of events 10
|
|
Investigations
Body temperature increased
|
10.0%
2/20 • Number of events 2
|
|
Investigations
Haemoglobin decreased
|
5.0%
1/20 • Number of events 1
|
|
Investigations
Heart rate increased
|
10.0%
2/20 • Number of events 2
|
|
Investigations
Weight decreased
|
15.0%
3/20 • Number of events 3
|
|
Investigations
Weight increased
|
5.0%
1/20 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperalbuminaemia
|
5.0%
1/20 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
5.0%
1/20 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
25.0%
5/20 • Number of events 7
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
15.0%
3/20 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
20.0%
4/20 • Number of events 4
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
15.0%
3/20 • Number of events 4
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
30.0%
6/20 • Number of events 11
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
5.0%
1/20 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
5.0%
1/20 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.0%
1/20 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
15.0%
3/20 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
15.0%
3/20 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
2/20 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
55.0%
11/20 • Number of events 17
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
5.0%
1/20 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.0%
1/20 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
5.0%
1/20 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.0%
1/20 • Number of events 1
|
|
Nervous system disorders
Burning sensation mucosal
|
5.0%
1/20 • Number of events 3
|
|
Nervous system disorders
Dizziness
|
10.0%
2/20 • Number of events 3
|
|
Nervous system disorders
Headache
|
20.0%
4/20 • Number of events 5
|
|
Psychiatric disorders
Anorexia nervosa
|
5.0%
1/20 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
5.0%
1/20 • Number of events 1
|
|
Psychiatric disorders
Nervousness
|
5.0%
1/20 • Number of events 1
|
|
Renal and urinary disorders
Bladder discomfort
|
5.0%
1/20 • Number of events 1
|
|
Renal and urinary disorders
Dysuria
|
5.0%
1/20 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
5/20 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.0%
1/20 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
15.0%
3/20 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.0%
1/20 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.0%
1/20 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
5.0%
1/20 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Acne
|
5.0%
1/20 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
5.0%
1/20 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.0%
1/20 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
10.0%
2/20 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
10.0%
2/20 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.0%
1/20 • Number of events 4
|
|
Vascular disorders
Flushing
|
5.0%
1/20 • Number of events 1
|
|
Vascular disorders
Hypertension
|
10.0%
2/20 • Number of events 2
|
|
Vascular disorders
Pallor
|
5.0%
1/20 • Number of events 1
|
Additional Information
Senior Administrator, Compliance - Clinical Research Services
Roswell Park Cancer Institute
Phone: 716-845-2300
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place