Trial Outcomes & Findings for Bortezomib and Lenalidomide in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma (NCT NCT00553644)
NCT ID: NCT00553644
Last Updated: 2018-10-30
Results Overview
Response is assessed by investigator according to International Working Group (IWG) criteria. A complete response requires disappearance of all evidence of disease. A partial response is a \>/= 50% decrease in the sum of products of 6 largest dominant nodes or nodal masses as well as for splenic and hepatic nodules. No increase in size of nodes, liver or spleen and no new sites of disease.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
53 participants
Primary outcome timeframe
Duration of treatment (assessed up to 6 years)
Results posted on
2018-10-30
Participant Flow
Between November 2007 and July 2011, 54 participants were recruited to this study.
One participant was deemed ineligible and removed for all analyses; therefore, 53 participants were analyzed.
Participant milestones
| Measure |
Treatment (Antiangiogenesis Therapy, Enzyme Inhibitor Therapy)
Patients receive induction therapy comprising bortezomib 1.3mg/m\^2 IV over 3-5 seconds on days 1, 4, 8, and 11 and lenalidomide 20 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete or partial response as best response after completion of induction therapy receive maintenance therapy comprising bortezomib 1.3 mg/m\^2 IV on days 1 and 8 and lenalidomide 15 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 6 years in the absence of disease progression or unacceptable toxicity.
bortezomib: Given IV
lenalidomide: Given PO
|
|---|---|
|
Overall Study
STARTED
|
53
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
28
|
Reasons for withdrawal
| Measure |
Treatment (Antiangiogenesis Therapy, Enzyme Inhibitor Therapy)
Patients receive induction therapy comprising bortezomib 1.3mg/m\^2 IV over 3-5 seconds on days 1, 4, 8, and 11 and lenalidomide 20 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete or partial response as best response after completion of induction therapy receive maintenance therapy comprising bortezomib 1.3 mg/m\^2 IV on days 1 and 8 and lenalidomide 15 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 6 years in the absence of disease progression or unacceptable toxicity.
bortezomib: Given IV
lenalidomide: Given PO
|
|---|---|
|
Overall Study
Adverse Event
|
17
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Alternative therapy
|
6
|
Baseline Characteristics
Bortezomib and Lenalidomide in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma
Baseline characteristics by cohort
| Measure |
Treatment (Antiangiogenesis Therapy, Enzyme Inhibitor Therapy)
n=53 Participants
Patients receive induction therapy comprising bortezomib 1.3mg/m\^2 IV over 3-5 seconds on days 1, 4, 8, and 11 and lenalidomide 20 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete or partial response as best response after completion of induction therapy receive maintenance therapy comprising bortezomib 1.3 mg/m\^2 IV on days 1 and 8 and lenalidomide 15 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 6 years in the absence of disease progression or unacceptable toxicity.
bortezomib: Given IV
lenalidomide: Given PO
|
|---|---|
|
Age, Continuous
|
67 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
53 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Duration of treatment (assessed up to 6 years)Response is assessed by investigator according to International Working Group (IWG) criteria. A complete response requires disappearance of all evidence of disease. A partial response is a \>/= 50% decrease in the sum of products of 6 largest dominant nodes or nodal masses as well as for splenic and hepatic nodules. No increase in size of nodes, liver or spleen and no new sites of disease.
Outcome measures
| Measure |
Treatment (Antiangiogenesis Therapy, Enzyme Inhibitor Therapy)
n=53 Participants
Patients receive induction therapy comprising bortezomib 1.3mg/m\^2 IV over 3-5 seconds on days 1, 4, 8, and 11 and lenalidomide 20 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete or partial response as best response after completion of induction therapy receive maintenance therapy comprising bortezomib 1.3 mg/m\^2 IV on days 1 and 8 and lenalidomide 15 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 6 years in the absence of disease progression or unacceptable toxicity.
bortezomib: Given IV
lenalidomide: Given PO
|
|---|---|
|
Number of Participants With an Overall Response Defined as Complete Response and Partial Response
|
21 participants
|
SECONDARY outcome
Timeframe: Duration of Treatment (up to 6 years)Number of participants who experienced a maximum grade 3, 4 or 5 adverse event. The grading scales found in the revised NCI CTCAE version 4.0 was utilized for adverse event reporting
Outcome measures
| Measure |
Treatment (Antiangiogenesis Therapy, Enzyme Inhibitor Therapy)
n=53 Participants
Patients receive induction therapy comprising bortezomib 1.3mg/m\^2 IV over 3-5 seconds on days 1, 4, 8, and 11 and lenalidomide 20 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete or partial response as best response after completion of induction therapy receive maintenance therapy comprising bortezomib 1.3 mg/m\^2 IV on days 1 and 8 and lenalidomide 15 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 6 years in the absence of disease progression or unacceptable toxicity.
bortezomib: Given IV
lenalidomide: Given PO
|
|---|---|
|
Incidence of Adverse Events
Grade 2
|
4 participants
|
|
Incidence of Adverse Events
Grade 3
|
29 participants
|
|
Incidence of Adverse Events
Grade 4
|
17 participants
|
|
Incidence of Adverse Events
Grade 5
|
1 participants
|
SECONDARY outcome
Timeframe: Assessed up to 6 yearsTime to progression (TTP) is defined as the time from study entry until progression or death due to any cause. The median TTP with 95% CI was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Treatment (Antiangiogenesis Therapy, Enzyme Inhibitor Therapy)
n=53 Participants
Patients receive induction therapy comprising bortezomib 1.3mg/m\^2 IV over 3-5 seconds on days 1, 4, 8, and 11 and lenalidomide 20 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete or partial response as best response after completion of induction therapy receive maintenance therapy comprising bortezomib 1.3 mg/m\^2 IV on days 1 and 8 and lenalidomide 15 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 6 years in the absence of disease progression or unacceptable toxicity.
bortezomib: Given IV
lenalidomide: Given PO
|
|---|---|
|
Time to Progression
|
0.58 years
Interval 0.29 to 1.15
|
SECONDARY outcome
Timeframe: Assessed up to 6 yearsOverall survival (OS) is defined as the time from study entry until death. The median OS with 95% CI was estimated using the Kaplan-Meier method..
Outcome measures
| Measure |
Treatment (Antiangiogenesis Therapy, Enzyme Inhibitor Therapy)
n=53 Participants
Patients receive induction therapy comprising bortezomib 1.3mg/m\^2 IV over 3-5 seconds on days 1, 4, 8, and 11 and lenalidomide 20 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete or partial response as best response after completion of induction therapy receive maintenance therapy comprising bortezomib 1.3 mg/m\^2 IV on days 1 and 8 and lenalidomide 15 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 6 years in the absence of disease progression or unacceptable toxicity.
bortezomib: Given IV
lenalidomide: Given PO
|
|---|---|
|
Overall Survival
|
2.17 years
Interval 1.15 to 4.58
|
Adverse Events
Treatment (Antiangiogenesis Therapy, Enzyme Inhibitor Therapy)
Serious events: 24 serious events
Other events: 48 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Antiangiogenesis Therapy, Enzyme Inhibitor Therapy)
n=53 participants at risk
lenalidomide: Given PO
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.9%
1/53 • Number of events 1
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
35.8%
19/53 • Number of events 23
|
|
Cardiac disorders
Mobitz type I
|
1.9%
1/53 • Number of events 1
|
|
Eye disorders
Diplopia
|
1.9%
1/53 • Number of events 1
|
|
Eye disorders
Eye disorder
|
1.9%
1/53 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
7.5%
4/53 • Number of events 4
|
|
Gastrointestinal disorders
Constipation
|
5.7%
3/53 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhea
|
15.1%
8/53 • Number of events 8
|
|
Gastrointestinal disorders
Dry mouth
|
1.9%
1/53 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia
|
1.9%
1/53 • Number of events 1
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
3.8%
2/53 • Number of events 2
|
|
Gastrointestinal disorders
Ileus
|
1.9%
1/53 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
17.0%
9/53 • Number of events 9
|
|
Gastrointestinal disorders
Oral pain
|
1.9%
1/53 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
11.3%
6/53 • Number of events 6
|
|
General disorders
Disease progression
|
5.7%
3/53 • Number of events 3
|
|
General disorders
Edema limbs
|
7.5%
4/53 • Number of events 4
|
|
General disorders
Facial pain
|
1.9%
1/53 • Number of events 1
|
|
General disorders
Fatigue
|
28.3%
15/53 • Number of events 18
|
|
General disorders
Fever
|
11.3%
6/53 • Number of events 7
|
|
Infections and infestations
Abdominal infection
|
1.9%
1/53 • Number of events 1
|
|
Infections and infestations
Conjunctivitis infective
|
1.9%
1/53 • Number of events 1
|
|
Infections and infestations
Infection
|
3.8%
2/53 • Number of events 2
|
|
Infections and infestations
Otitis externa
|
1.9%
1/53 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
3.8%
2/53 • Number of events 2
|
|
Infections and infestations
Sepsis
|
3.8%
2/53 • Number of events 2
|
|
Infections and infestations
Upper respiratory infection
|
1.9%
1/53 • Number of events 1
|
|
Injury, poisoning and procedural complications
Intraoperative complications
|
1.9%
1/53 • Number of events 1
|
|
Investigations
Activated partial thromboplastin time prolonged
|
1.9%
1/53 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
9.4%
5/53 • Number of events 6
|
|
Investigations
Alkaline phosphatase increased
|
9.4%
5/53 • Number of events 5
|
|
Investigations
Aspartate aminotransferase increased
|
9.4%
5/53 • Number of events 5
|
|
Investigations
Blood bilirubin increased
|
5.7%
3/53 • Number of events 4
|
|
Investigations
Creatinine increased
|
13.2%
7/53 • Number of events 8
|
|
Investigations
INR increased
|
1.9%
1/53 • Number of events 2
|
|
Investigations
Leukocyte count decreased
|
20.8%
11/53 • Number of events 11
|
|
Investigations
Lymphocyte count decreased
|
11.3%
6/53 • Number of events 8
|
|
Investigations
Neutrophil count decreased
|
20.8%
11/53 • Number of events 12
|
|
Investigations
Platelet count decreased
|
37.7%
20/53 • Number of events 24
|
|
Investigations
Weight loss
|
3.8%
2/53 • Number of events 2
|
|
Metabolism and nutrition disorders
Anorexia
|
11.3%
6/53 • Number of events 6
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
9.4%
5/53 • Number of events 6
|
|
Metabolism and nutrition disorders
Blood uric acid increased
|
3.8%
2/53 • Number of events 3
|
|
Metabolism and nutrition disorders
Dehydration
|
5.7%
3/53 • Number of events 3
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
15.1%
8/53 • Number of events 8
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
20.8%
11/53 • Number of events 12
|
|
Metabolism and nutrition disorders
Serum calcium increased
|
1.9%
1/53 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
1.9%
1/53 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
3.8%
2/53 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
5.7%
3/53 • Number of events 3
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
5.7%
3/53 • Number of events 3
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
3.8%
2/53 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
7.5%
4/53 • Number of events 4
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
3.8%
2/53 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.7%
3/53 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
3.8%
2/53 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
7.5%
4/53 • Number of events 4
|
|
Nervous system disorders
Dysgeusia
|
1.9%
1/53 • Number of events 2
|
|
Nervous system disorders
Facial muscle weakness
|
1.9%
1/53 • Number of events 1
|
|
Nervous system disorders
Headache
|
1.9%
1/53 • Number of events 1
|
|
Nervous system disorders
Ischemia cerebrovascular
|
1.9%
1/53 • Number of events 1
|
|
Nervous system disorders
Neuralgia
|
1.9%
1/53 • Number of events 1
|
|
Nervous system disorders
Neurological disorder NOS
|
3.8%
2/53 • Number of events 2
|
|
Nervous system disorders
Oculomotor nerve disorder
|
1.9%
1/53 • Number of events 1
|
|
Nervous system disorders
Peripheral motor neuropathy
|
5.7%
3/53 • Number of events 3
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
11.3%
6/53 • Number of events 8
|
|
Nervous system disorders
Speech disorder
|
1.9%
1/53 • Number of events 1
|
|
Nervous system disorders
Syncope
|
5.7%
3/53 • Number of events 3
|
|
Nervous system disorders
Trigeminal nerve disorder
|
1.9%
1/53 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
1.9%
1/53 • Number of events 1
|
|
Psychiatric disorders
Confusion
|
1.9%
1/53 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
3.8%
2/53 • Number of events 2
|
|
Renal and urinary disorders
Renal failure
|
1.9%
1/53 • Number of events 1
|
|
Renal and urinary disorders
Urogenital disorder
|
1.9%
1/53 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
3.8%
2/53 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.7%
3/53 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
15.1%
8/53 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.8%
2/53 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.8%
2/53 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.7%
3/53 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.7%
3/53 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
1.9%
1/53 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
1.9%
1/53 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.8%
2/53 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
1.9%
1/53 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
1.9%
1/53 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Sweating
|
1.9%
1/53 • Number of events 1
|
|
Vascular disorders
Hemorrhage
|
1.9%
1/53 • Number of events 1
|
|
Vascular disorders
Hypertension
|
1.9%
1/53 • Number of events 1
|
|
Vascular disorders
Hypotension
|
9.4%
5/53 • Number of events 6
|
|
Vascular disorders
Thrombosis
|
3.8%
2/53 • Number of events 2
|
Other adverse events
| Measure |
Treatment (Antiangiogenesis Therapy, Enzyme Inhibitor Therapy)
n=53 participants at risk
lenalidomide: Given PO
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
71.7%
38/53 • Number of events 200
|
|
Blood and lymphatic system disorders
Lymph node pain
|
3.8%
2/53 • Number of events 4
|
|
Cardiac disorders
Cardiac pain
|
1.9%
1/53 • Number of events 1
|
|
Cardiac disorders
Left ventricular failure
|
1.9%
1/53 • Number of events 1
|
|
Cardiac disorders
Palpitations
|
1.9%
1/53 • Number of events 1
|
|
Cardiac disorders
Sinus bradycardia
|
3.8%
2/53 • Number of events 5
|
|
Cardiac disorders
Sinus tachycardia
|
1.9%
1/53 • Number of events 1
|
|
Cardiac disorders
Ventricular trigeminy
|
1.9%
1/53 • Number of events 1
|
|
Ear and labyrinth disorders
Hearing impaired
|
1.9%
1/53 • Number of events 1
|
|
Endocrine disorders
Hypothyroidism
|
1.9%
1/53 • Number of events 1
|
|
Eye disorders
Diplopia
|
1.9%
1/53 • Number of events 1
|
|
Eye disorders
Dry eye syndrome
|
3.8%
2/53 • Number of events 12
|
|
Eye disorders
Eye disorder
|
3.8%
2/53 • Number of events 2
|
|
Eye disorders
Flashing vision
|
1.9%
1/53 • Number of events 3
|
|
Eye disorders
Vision blurred
|
9.4%
5/53 • Number of events 11
|
|
Gastrointestinal disorders
Abdominal distension
|
1.9%
1/53 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain
|
15.1%
8/53 • Number of events 11
|
|
Gastrointestinal disorders
Ascites
|
1.9%
1/53 • Number of events 2
|
|
Gastrointestinal disorders
Colonic hemorrhage
|
1.9%
1/53 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
37.7%
20/53 • Number of events 76
|
|
Gastrointestinal disorders
Diarrhea
|
41.5%
22/53 • Number of events 65
|
|
Gastrointestinal disorders
Dry mouth
|
3.8%
2/53 • Number of events 3
|
|
Gastrointestinal disorders
Dyspepsia
|
5.7%
3/53 • Number of events 4
|
|
Gastrointestinal disorders
Dysphagia
|
1.9%
1/53 • Number of events 3
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
3.8%
2/53 • Number of events 2
|
|
Gastrointestinal disorders
Esophagitis
|
1.9%
1/53 • Number of events 1
|
|
Gastrointestinal disorders
Flatulence
|
3.8%
2/53 • Number of events 3
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
5.7%
3/53 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
34.0%
18/53 • Number of events 44
|
|
Gastrointestinal disorders
Oral pain
|
1.9%
1/53 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
18.9%
10/53 • Number of events 15
|
|
General disorders
Chills
|
7.5%
4/53 • Number of events 7
|
|
General disorders
Edema limbs
|
20.8%
11/53 • Number of events 19
|
|
General disorders
Fatigue
|
69.8%
37/53 • Number of events 187
|
|
General disorders
Fever
|
11.3%
6/53 • Number of events 7
|
|
General disorders
Flu-like symptoms
|
1.9%
1/53 • Number of events 1
|
|
General disorders
General symptom
|
1.9%
1/53 • Number of events 2
|
|
General disorders
Localized edema
|
1.9%
1/53 • Number of events 2
|
|
General disorders
Pain
|
3.8%
2/53 • Number of events 3
|
|
Immune system disorders
Hypersensitivity
|
1.9%
1/53 • Number of events 2
|
|
Immune system disorders
Immune system disorder
|
1.9%
1/53 • Number of events 35
|
|
Infections and infestations
Bronchitis
|
5.7%
3/53 • Number of events 5
|
|
Infections and infestations
Eye infection
|
3.8%
2/53 • Number of events 4
|
|
Infections and infestations
Lip infection
|
1.9%
1/53 • Number of events 1
|
|
Infections and infestations
Peripheral nerve infection
|
1.9%
1/53 • Number of events 1
|
|
Infections and infestations
Pharyngitis
|
1.9%
1/53 • Number of events 2
|
|
Infections and infestations
Pneumonia
|
7.5%
4/53 • Number of events 4
|
|
Infections and infestations
Rhinitis infective
|
1.9%
1/53 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
7.5%
4/53 • Number of events 10
|
|
Infections and infestations
Skin infection
|
7.5%
4/53 • Number of events 5
|
|
Infections and infestations
Upper respiratory infection
|
5.7%
3/53 • Number of events 4
|
|
Infections and infestations
Urinary tract infection
|
1.9%
1/53 • Number of events 1
|
|
Injury, poisoning and procedural complications
Bruising
|
1.9%
1/53 • Number of events 1
|
|
Investigations
Activated partial thromboplastin time prolonged
|
1.9%
1/53 • Number of events 2
|
|
Investigations
Alanine aminotransferase increased
|
20.8%
11/53 • Number of events 21
|
|
Investigations
Alkaline phosphatase increased
|
11.3%
6/53 • Number of events 11
|
|
Investigations
Aspartate aminotransferase increased
|
20.8%
11/53 • Number of events 18
|
|
Investigations
Blood bilirubin increased
|
5.7%
3/53 • Number of events 13
|
|
Investigations
Creatinine increased
|
20.8%
11/53 • Number of events 17
|
|
Investigations
INR increased
|
5.7%
3/53 • Number of events 5
|
|
Investigations
Laboratory test abnormal
|
1.9%
1/53 • Number of events 2
|
|
Investigations
Leukocyte count decreased
|
34.0%
18/53 • Number of events 106
|
|
Investigations
Lymphocyte count decreased
|
26.4%
14/53 • Number of events 49
|
|
Investigations
Neutrophil count decreased
|
39.6%
21/53 • Number of events 156
|
|
Investigations
Platelet count decreased
|
67.9%
36/53 • Number of events 203
|
|
Investigations
Weight loss
|
15.1%
8/53 • Number of events 13
|
|
Metabolism and nutrition disorders
Anorexia
|
30.2%
16/53 • Number of events 48
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
24.5%
13/53 • Number of events 67
|
|
Metabolism and nutrition disorders
Blood uric acid increased
|
7.5%
4/53 • Number of events 16
|
|
Metabolism and nutrition disorders
Dehydration
|
3.8%
2/53 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
18.9%
10/53 • Number of events 27
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
17.0%
9/53 • Number of events 41
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
11.3%
6/53 • Number of events 28
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
5.7%
3/53 • Number of events 4
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
5.7%
3/53 • Number of events 6
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
15.1%
8/53 • Number of events 12
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
1.9%
1/53 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.7%
3/53 • Number of events 20
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.8%
2/53 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.7%
3/53 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
11.3%
6/53 • Number of events 9
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
1.9%
1/53 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
1.9%
1/53 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.7%
3/53 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.7%
3/53 • Number of events 7
|
|
Nervous system disorders
Ataxia
|
5.7%
3/53 • Number of events 3
|
|
Nervous system disorders
Cognitive disturbance
|
1.9%
1/53 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
26.4%
14/53 • Number of events 33
|
|
Nervous system disorders
Dysgeusia
|
5.7%
3/53 • Number of events 6
|
|
Nervous system disorders
Extrapyramidal disorder
|
3.8%
2/53 • Number of events 8
|
|
Nervous system disorders
Headache
|
9.4%
5/53 • Number of events 9
|
|
Nervous system disorders
Neuralgia
|
7.5%
4/53 • Number of events 13
|
|
Nervous system disorders
Neurological disorder NOS
|
3.8%
2/53 • Number of events 3
|
|
Nervous system disorders
Peripheral motor neuropathy
|
13.2%
7/53 • Number of events 13
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
62.3%
33/53 • Number of events 281
|
|
Nervous system disorders
Sinus pain
|
1.9%
1/53 • Number of events 2
|
|
Nervous system disorders
Trigeminal nerve disorder
|
1.9%
1/53 • Number of events 1
|
|
Psychiatric disorders
Agitation
|
1.9%
1/53 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
1.9%
1/53 • Number of events 1
|
|
Psychiatric disorders
Confusion
|
1.9%
1/53 • Number of events 1
|
|
Psychiatric disorders
Depression
|
5.7%
3/53 • Number of events 5
|
|
Psychiatric disorders
Insomnia
|
9.4%
5/53 • Number of events 6
|
|
Psychiatric disorders
Psychosis
|
1.9%
1/53 • Number of events 1
|
|
Renal and urinary disorders
Urinary frequency
|
1.9%
1/53 • Number of events 1
|
|
Renal and urinary disorders
Urinary incontinence
|
1.9%
1/53 • Number of events 1
|
|
Renal and urinary disorders
Urinary retention
|
1.9%
1/53 • Number of events 1
|
|
Renal and urinary disorders
Urogenital disorder
|
1.9%
1/53 • Number of events 3
|
|
Reproductive system and breast disorders
Testicular pain
|
1.9%
1/53 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
7.5%
4/53 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
28.3%
15/53 • Number of events 23
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
37.7%
20/53 • Number of events 43
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.8%
2/53 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
1.9%
1/53 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.9%
1/53 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.9%
1/53 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
3.8%
2/53 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
5.7%
3/53 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.9%
1/53 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.7%
3/53 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
3.8%
2/53 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
1.9%
1/53 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
1.9%
1/53 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.8%
11/53 • Number of events 34
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
1.9%
1/53 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
26.4%
14/53 • Number of events 27
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
7.5%
4/53 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
1.9%
1/53 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Sweating
|
11.3%
6/53 • Number of events 10
|
|
Vascular disorders
Hypertension
|
3.8%
2/53 • Number of events 2
|
|
Vascular disorders
Hypotension
|
18.9%
10/53 • Number of events 16
|
|
Vascular disorders
Thrombosis
|
3.8%
2/53 • Number of events 2
|
Additional Information
Vicki Morrison, M.D.
Veterans Affairs Medical Center/University of Minnesota
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60