Trial Outcomes & Findings for Bortezomib After Combination Chemotherapy, Rituximab, and an Autologous Stem Cell Transplant in Treating Patients With Mantle Cell Lymphoma (NCT NCT00310037)
NCT ID: NCT00310037
Last Updated: 2025-10-28
Results Overview
Progression free survival (PFS) rate at 18 months was defined as the proportion of patients that were alive and progression-free 18 months after registration into the study. The Kaplan-Meier method of 18 month progression-free survival was calculated..
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
151 participants
Primary outcome timeframe
At 18 months
Results posted on
2025-10-28
Participant Flow
From June 2006 to June 2010, 151 participants were enrolled at 14 sites and 147 participants received protocol treatment.
Of the 147 participants who began treatment, 102 participants were randomized. Participants who were not randomized are excluded from all analyses per study design.
Participant milestones
| Measure |
Arm A Maintenance Therapy
Patients receive bortezomib 1.6 mg/m\^2 IV on days 1, 8, 15, and 22 once daily for 4 weeks. There will be a 4 week rest period. One cycle is a total of 8 weeks. A total of 10 cycles of bortezomib will be given in the absence of disease progression or unacceptable toxicity.
|
Arm B Consolidation Therapy
Patients receive bortezomib 1.3 mg/m\^2 IV on days 1, 4, 8, and 11 once daily for 3 weeks. One cycle is a total of 3 weeks. A total of 4 cycles of bortezomib will be given in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
50
|
|
Overall Study
COMPLETED
|
34
|
33
|
|
Overall Study
NOT COMPLETED
|
18
|
17
|
Reasons for withdrawal
| Measure |
Arm A Maintenance Therapy
Patients receive bortezomib 1.6 mg/m\^2 IV on days 1, 8, 15, and 22 once daily for 4 weeks. There will be a 4 week rest period. One cycle is a total of 8 weeks. A total of 10 cycles of bortezomib will be given in the absence of disease progression or unacceptable toxicity.
|
Arm B Consolidation Therapy
Patients receive bortezomib 1.3 mg/m\^2 IV on days 1, 4, 8, and 11 once daily for 3 weeks. One cycle is a total of 3 weeks. A total of 4 cycles of bortezomib will be given in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
Adverse Event
|
7
|
14
|
|
Overall Study
Withdrawal by Subject
|
4
|
3
|
|
Overall Study
Progression
|
6
|
0
|
|
Overall Study
Non-protocol treatment
|
1
|
0
|
Baseline Characteristics
Bortezomib After Combination Chemotherapy, Rituximab, and an Autologous Stem Cell Transplant in Treating Patients With Mantle Cell Lymphoma
Baseline characteristics by cohort
| Measure |
Arm A Maintenance Therapy
n=52 Participants
Patients receive bortezomib 1.6 mg/m\^2 IV on days 1, 8, 15, and 22 once daily for 4 weeks. There will be a 4 week rest period. One cycle is a total of 8 weeks. A total of 10 cycles of bortezomib will be given in the absence of disease progression or unacceptable toxicity.
|
Arm B Consolidation Therapy
n=50 Participants
Patients receive bortezomib 1.3 mg/m\^2 IV on days 1, 4, 8, and 11 once daily for 3 weeks. One cycle is a total of 3 weeks. A total of 4 cycles of bortezomib will be given in the absence of disease progression or unacceptable toxicity.
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58 years
n=5 Participants
|
59 years
n=7 Participants
|
58.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
46 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
52 participants
n=5 Participants
|
50 participants
n=7 Participants
|
102 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 18 monthsProgression free survival (PFS) rate at 18 months was defined as the proportion of patients that were alive and progression-free 18 months after registration into the study. The Kaplan-Meier method of 18 month progression-free survival was calculated..
Outcome measures
| Measure |
Arm A Maintenance Therapy
n=52 Participants
Patients receive bortezomib 1.6 mg/m\^2 IV on days 1, 8, 15, and 22 once daily for 4 weeks. There will be a 4 week rest period. One cycle is a total of 8 weeks. A total of 10 cycles of bortezomib will be given in the absence of disease progression or unacceptable toxicity.
|
Arm B Consolidation Therapy
n=50 Participants
Patients receive bortezomib 1.3 mg/m\^2 IV on days 1, 4, 8, and 11 once daily for 3 weeks. One cycle is a total of 3 weeks. A total of 4 cycles of bortezomib will be given in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Progression-free Survival Rate at 18 Months
|
88.5 percentage of participants
Interval 80.2 to 97.6
|
96 percentage of participants
Interval 90.7 to 100.0
|
SECONDARY outcome
Timeframe: Up to 10 yearsOverall Survival (OS) was measured from the date of study entry to date of death due to any cause. The median OS with 95% CI was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Arm A Maintenance Therapy
n=52 Participants
Patients receive bortezomib 1.6 mg/m\^2 IV on days 1, 8, 15, and 22 once daily for 4 weeks. There will be a 4 week rest period. One cycle is a total of 8 weeks. A total of 10 cycles of bortezomib will be given in the absence of disease progression or unacceptable toxicity.
|
Arm B Consolidation Therapy
n=50 Participants
Patients receive bortezomib 1.3 mg/m\^2 IV on days 1, 4, 8, and 11 once daily for 3 weeks. One cycle is a total of 3 weeks. A total of 4 cycles of bortezomib will be given in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Survival
|
NA years
The median, lower and upper limits for overall survival have not been reached.
|
8.9 years
Interval 7.2 to
The upper limit was not calculable because an insufficient number of participants reached the event.
|
SECONDARY outcome
Timeframe: Up to 10 yearsComplete response is: * Complete disappearance of all detectable clinical and radiographic evidence of target lesions and disappearance of all disease-related symptoms if present prior to therapy and normalization of biochemical abnormalities definitely assignable to NHL * All lymph nodes and nodal masses must have regressed to normal size (\<= 1.5 cm in the greatest transverse diameter (GTD) for nodes \> 1.5 cm prior to therapy) or \<= 1 cm for nodes that were 1.1-1.5 cm in the GTD prior to therapy or by more than 75% in the sum of the products of the GTD * The spleen, if enlarged before therapy, must have regressed in size and must not be palpable on physical examination. Any macroscopic nodules in any organs detectable on imaging studies should no longer be present. Other organs enlarged prior to therapy due to involvement of lymphoma must have decreased in size * If bone marrow was involved by lymphoma prior to treatment, infiltrate must be cleared on repeat bone marrow aspirate
Outcome measures
| Measure |
Arm A Maintenance Therapy
n=52 Participants
Patients receive bortezomib 1.6 mg/m\^2 IV on days 1, 8, 15, and 22 once daily for 4 weeks. There will be a 4 week rest period. One cycle is a total of 8 weeks. A total of 10 cycles of bortezomib will be given in the absence of disease progression or unacceptable toxicity.
|
Arm B Consolidation Therapy
n=80 Participants
Patients receive bortezomib 1.3 mg/m\^2 IV on days 1, 4, 8, and 11 once daily for 3 weeks. One cycle is a total of 3 weeks. A total of 4 cycles of bortezomib will be given in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Number of Participants With Complete Response Intensive Chemo-immunotherapy Plus Maintenance or Consolidation Bortezomib
|
31 participants
|
35 participants
|
SECONDARY outcome
Timeframe: Duration of treatment (up to approximately 2 years)The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life Threatening; Grade 5: Death.
Outcome measures
| Measure |
Arm A Maintenance Therapy
n=52 Participants
Patients receive bortezomib 1.6 mg/m\^2 IV on days 1, 8, 15, and 22 once daily for 4 weeks. There will be a 4 week rest period. One cycle is a total of 8 weeks. A total of 10 cycles of bortezomib will be given in the absence of disease progression or unacceptable toxicity.
|
Arm B Consolidation Therapy
n=50 Participants
Patients receive bortezomib 1.3 mg/m\^2 IV on days 1, 4, 8, and 11 once daily for 3 weeks. One cycle is a total of 3 weeks. A total of 4 cycles of bortezomib will be given in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Number of Participants With Grade 3, 4 or 5 Adverse Event at Least Possibly Related to Treatment.
|
52 participants
|
50 participants
|
Adverse Events
Arm A Maintenance Therapy
Serious events: 13 serious events
Other events: 52 other events
Deaths: 0 deaths
Arm B Consolidation Therapy
Serious events: 10 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A Maintenance Therapy
n=52 participants at risk
Patients receive bortezomib 1.6 mg/m\^2 IV on days 1, 8, 15, and 22 once daily for 4 weeks. There will be a 4 week rest period. One cycle is a total of 8 weeks. A total of 10 cycles of bortezomib will be given in the absence of disease progression or unacceptable toxicity.
|
Arm B Consolidation Therapy
n=50 participants at risk
Patients receive bortezomib 1.3 mg/m\^2 IV on days 1, 4, 8, and 11 once daily for 3 weeks. One cycle is a total of 3 weeks. A total of 4 cycles of bortezomib will be given in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Infections and infestations
Infectious meningitis
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Infections and infestations
Pneumonia
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
|
Infections and infestations
Sepsis
|
5.8%
3/52 • Number of events 3
|
4.0%
2/50 • Number of events 2
|
|
Infections and infestations
Skin infection
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Infections and infestations
Ureteritis
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
1.9%
1/52 • Number of events 1
|
2.0%
1/50 • Number of events 2
|
|
Investigations
Activated partial thromboplastin time prolonged
|
1.9%
1/52 • Number of events 1
|
6.0%
3/50 • Number of events 4
|
|
Investigations
Alanine aminotransferase increased
|
9.6%
5/52 • Number of events 7
|
6.0%
3/50 • Number of events 3
|
|
Investigations
Alkaline phosphatase increased
|
5.8%
3/52 • Number of events 3
|
4.0%
2/50 • Number of events 2
|
|
Investigations
Aspartate aminotransferase increased
|
13.5%
7/52 • Number of events 7
|
6.0%
3/50 • Number of events 3
|
|
Investigations
Blood bilirubin increased
|
7.7%
4/52 • Number of events 4
|
8.0%
4/50 • Number of events 4
|
|
Investigations
Creatinine increased
|
7.7%
4/52 • Number of events 4
|
2.0%
1/50 • Number of events 1
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Investigations
INR increased
|
0.00%
0/52
|
6.0%
3/50 • Number of events 4
|
|
Investigations
Leukocyte count decreased
|
15.4%
8/52 • Number of events 11
|
12.0%
6/50 • Number of events 7
|
|
Investigations
Lymphocyte count decreased
|
15.4%
8/52 • Number of events 10
|
18.0%
9/50 • Number of events 9
|
|
Investigations
Neutrophil count decreased
|
19.2%
10/52 • Number of events 12
|
14.0%
7/50 • Number of events 9
|
|
Investigations
Platelet count decreased
|
21.2%
11/52 • Number of events 15
|
18.0%
9/50 • Number of events 11
|
|
Investigations
Weight loss
|
3.8%
2/52 • Number of events 2
|
2.0%
1/50 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
7.7%
4/52 • Number of events 5
|
10.0%
5/50 • Number of events 5
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
11.5%
6/52 • Number of events 7
|
10.0%
5/50 • Number of events 6
|
|
Metabolism and nutrition disorders
Blood uric acid increased
|
3.8%
2/52 • Number of events 2
|
2.0%
1/50 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
9.6%
5/52 • Number of events 5
|
8.0%
4/50 • Number of events 5
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
13.5%
7/52 • Number of events 8
|
10.0%
5/50 • Number of events 6
|
|
Metabolism and nutrition disorders
Serum calcium increased
|
1.9%
1/52 • Number of events 1
|
4.0%
2/50 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
0.00%
0/52
|
6.0%
3/50 • Number of events 3
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
1.9%
1/52 • Number of events 2
|
4.0%
2/50 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
0.00%
0/52
|
8.0%
4/50 • Number of events 4
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
7.7%
4/52 • Number of events 5
|
10.0%
5/50 • Number of events 6
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
11.5%
6/52 • Number of events 6
|
6.0%
3/50 • Number of events 3
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
0.00%
0/52
|
4.0%
2/50 • Number of events 3
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.8%
2/52 • Number of events 3
|
2.0%
1/50 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
0.00%
0/52
|
4.0%
2/50 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.9%
1/52 • Number of events 2
|
0.00%
0/50
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Nervous system disorders
Ataxia
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Nervous system disorders
Dizziness
|
0.00%
0/52
|
6.0%
3/50 • Number of events 3
|
|
Nervous system disorders
Headache
|
9.6%
5/52 • Number of events 5
|
6.0%
3/50 • Number of events 5
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
|
Nervous system disorders
Peripheral motor neuropathy
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
7.7%
4/52 • Number of events 5
|
4.0%
2/50 • Number of events 2
|
|
Nervous system disorders
Syncope
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
5.8%
3/52 • Number of events 4
|
0.00%
0/50
|
|
Psychiatric disorders
Confusion
|
0.00%
0/52
|
6.0%
3/50 • Number of events 3
|
|
Psychiatric disorders
Depression
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Psychiatric disorders
Insomnia
|
1.9%
1/52 • Number of events 2
|
4.0%
2/50 • Number of events 2
|
|
Renal and urinary disorders
Urogenital disorder
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
1.9%
1/52 • Number of events 1
|
2.0%
1/50 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.8%
3/52 • Number of events 3
|
6.0%
3/50 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.8%
2/52 • Number of events 2
|
4.0%
2/50 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
1.9%
1/52 • Number of events 1
|
2.0%
1/50 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.8%
2/52 • Number of events 2
|
4.0%
2/50 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.8%
3/52 • Number of events 3
|
0.00%
0/50
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.8%
2/52 • Number of events 2
|
8.0%
4/50 • Number of events 4
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
19.2%
10/52 • Number of events 15
|
18.0%
9/50 • Number of events 10
|
|
Cardiac disorders
Palpitations
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/52
|
4.0%
2/50 • Number of events 2
|
|
Eye disorders
Photophobia
|
1.9%
1/52 • Number of events 1
|
2.0%
1/50 • Number of events 1
|
|
Eye disorders
Vision blurred
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
|
Eye disorders
Watering eyes
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
9.6%
5/52 • Number of events 5
|
4.0%
2/50 • Number of events 2
|
|
Gastrointestinal disorders
Colitis
|
1.9%
1/52 • Number of events 1
|
2.0%
1/50 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
5.8%
3/52 • Number of events 3
|
2.0%
1/50 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
13.5%
7/52 • Number of events 8
|
8.0%
4/50 • Number of events 5
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
0.00%
0/52
|
4.0%
2/50 • Number of events 2
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
|
Gastrointestinal disorders
Gingival pain
|
1.9%
1/52 • Number of events 1
|
2.0%
1/50 • Number of events 1
|
|
Gastrointestinal disorders
Ileus
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Gastrointestinal disorders
Mucositis oral
|
5.8%
3/52 • Number of events 4
|
4.0%
2/50 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
13.5%
7/52 • Number of events 8
|
10.0%
5/50 • Number of events 7
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
|
Gastrointestinal disorders
Rectal pain
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Gastrointestinal disorders
Toothache
|
3.8%
2/52 • Number of events 2
|
0.00%
0/50
|
|
Gastrointestinal disorders
Vomiting
|
7.7%
4/52 • Number of events 5
|
6.0%
3/50 • Number of events 3
|
|
General disorders
Chest pain
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
|
General disorders
Chills
|
5.8%
3/52 • Number of events 3
|
6.0%
3/50 • Number of events 3
|
|
General disorders
Edema limbs
|
5.8%
3/52 • Number of events 3
|
4.0%
2/50 • Number of events 2
|
|
General disorders
Fatigue
|
15.4%
8/52 • Number of events 8
|
10.0%
5/50 • Number of events 5
|
|
General disorders
Fever
|
5.8%
3/52 • Number of events 3
|
8.0%
4/50 • Number of events 4
|
|
General disorders
Pain
|
3.8%
2/52 • Number of events 2
|
2.0%
1/50 • Number of events 1
|
|
Immune system disorders
Cytokine release syndrome
|
3.8%
2/52 • Number of events 2
|
4.0%
2/50 • Number of events 2
|
|
Immune system disorders
Hypersensitivity
|
1.9%
1/52 • Number of events 1
|
6.0%
3/50 • Number of events 3
|
|
Infections and infestations
Catheter related infection
|
1.9%
1/52 • Number of events 1
|
2.0%
1/50 • Number of events 1
|
|
Infections and infestations
Colitis, infectious (e.g., Clostridium difficile)
|
1.9%
1/52 • Number of events 2
|
0.00%
0/50
|
|
Infections and infestations
Infectious colitis
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
7.7%
4/52 • Number of events 4
|
4.0%
2/50 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Skin and subcutaneous tissue disorders
Sweating
|
1.9%
1/52 • Number of events 1
|
2.0%
1/50 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Vascular disorders
Flushing
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Vascular disorders
Hypertension
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Vascular disorders
Hypotension
|
5.8%
3/52 • Number of events 3
|
4.0%
2/50 • Number of events 2
|
Other adverse events
| Measure |
Arm A Maintenance Therapy
n=52 participants at risk
Patients receive bortezomib 1.6 mg/m\^2 IV on days 1, 8, 15, and 22 once daily for 4 weeks. There will be a 4 week rest period. One cycle is a total of 8 weeks. A total of 10 cycles of bortezomib will be given in the absence of disease progression or unacceptable toxicity.
|
Arm B Consolidation Therapy
n=50 participants at risk
Patients receive bortezomib 1.3 mg/m\^2 IV on days 1, 4, 8, and 11 once daily for 3 weeks. One cycle is a total of 3 weeks. A total of 4 cycles of bortezomib will be given in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
61.5%
32/52 • Number of events 46
|
54.0%
27/50 • Number of events 43
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
73.1%
38/52 • Number of events 357
|
88.0%
44/50 • Number of events 307
|
|
Blood and lymphatic system disorders
Hemolysis
|
5.8%
3/52 • Number of events 3
|
6.0%
3/50 • Number of events 7
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/52
|
6.0%
3/50 • Number of events 3
|
|
Blood and lymphatic system disorders
Lymphatic disorder
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
|
Blood and lymphatic system disorders
Transfusion: Platelets
|
1.9%
1/52 • Number of events 2
|
0.00%
0/50
|
|
Blood and lymphatic system disorders
Transfusion: pRBCs
|
1.9%
1/52 • Number of events 2
|
0.00%
0/50
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
7.7%
4/52 • Number of events 4
|
6.0%
3/50 • Number of events 5
|
|
Cardiac disorders
Atrial flutter
|
1.9%
1/52 • Number of events 1
|
2.0%
1/50 • Number of events 1
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
|
Cardiac disorders
Cardiac disorder
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Cardiac disorders
Cardiac pain
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Cardiac disorders
Cardiac valve disease
|
1.9%
1/52 • Number of events 1
|
4.0%
2/50 • Number of events 2
|
|
Cardiac disorders
Conduction disorder
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
|
Cardiac disorders
Edema
|
5.8%
3/52 • Number of events 5
|
2.0%
1/50 • Number of events 2
|
|
Cardiac disorders
Left ventricular failure
|
5.8%
3/52 • Number of events 3
|
2.0%
1/50 • Number of events 1
|
|
Cardiac disorders
Palpitations
|
5.8%
3/52 • Number of events 4
|
6.0%
3/50 • Number of events 12
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/52
|
4.0%
2/50 • Number of events 2
|
|
Cardiac disorders
Pericarditis
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Cardiac disorders
Sinus arrhythmia
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Cardiac disorders
Sinus bradycardia
|
5.8%
3/52 • Number of events 5
|
0.00%
0/50
|
|
Cardiac disorders
Sinus tachycardia
|
15.4%
8/52 • Number of events 9
|
12.0%
6/50 • Number of events 7
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/52
|
2.0%
1/50 • Number of events 2
|
|
Cardiac disorders
Supraventricular tachycardia
|
3.8%
2/52 • Number of events 3
|
4.0%
2/50 • Number of events 2
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
|
Cardiac disorders
Ventricular tachycardia
|
1.9%
1/52 • Number of events 1
|
2.0%
1/50 • Number of events 1
|
|
Ear and labyrinth disorders
Ear disorder
|
0.00%
0/52
|
4.0%
2/50 • Number of events 2
|
|
Ear and labyrinth disorders
Ear pain
|
1.9%
1/52 • Number of events 1
|
2.0%
1/50 • Number of events 2
|
|
Ear and labyrinth disorders
External ear pain
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Ear and labyrinth disorders
Hearing impaired
|
5.8%
3/52 • Number of events 4
|
0.00%
0/50
|
|
Ear and labyrinth disorders
Tinnitus
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Eye disorders
Conjunctivitis
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Eye disorders
Diplopia
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
|
Eye disorders
Dry eye syndrome
|
7.7%
4/52 • Number of events 8
|
8.0%
4/50 • Number of events 6
|
|
Eye disorders
Extraocular muscle paresis
|
0.00%
0/52
|
4.0%
2/50 • Number of events 5
|
|
Eye disorders
Eye disorder
|
7.7%
4/52 • Number of events 6
|
4.0%
2/50 • Number of events 2
|
|
Eye disorders
Eye pain
|
1.9%
1/52 • Number of events 1
|
4.0%
2/50 • Number of events 2
|
|
Eye disorders
Photophobia
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Eye disorders
Vision blurred
|
13.5%
7/52 • Number of events 11
|
6.0%
3/50 • Number of events 4
|
|
Eye disorders
Watering eyes
|
5.8%
3/52 • Number of events 3
|
0.00%
0/50
|
|
Gastrointestinal disorders
Abdominal distension
|
11.5%
6/52 • Number of events 10
|
4.0%
2/50 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal pain
|
30.8%
16/52 • Number of events 32
|
36.0%
18/50 • Number of events 29
|
|
Gastrointestinal disorders
Anal pain
|
0.00%
0/52
|
4.0%
2/50 • Number of events 2
|
|
Gastrointestinal disorders
Colitis
|
3.8%
2/52 • Number of events 2
|
0.00%
0/50
|
|
Gastrointestinal disorders
Colonic hemorrhage
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Gastrointestinal disorders
Constipation
|
53.8%
28/52 • Number of events 59
|
56.0%
28/50 • Number of events 70
|
|
Gastrointestinal disorders
Diarrhea
|
86.5%
45/52 • Number of events 144
|
90.0%
45/50 • Number of events 124
|
|
Gastrointestinal disorders
Dry mouth
|
3.8%
2/52 • Number of events 2
|
2.0%
1/50 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
23.1%
12/52 • Number of events 14
|
18.0%
9/50 • Number of events 17
|
|
Gastrointestinal disorders
Dysphagia
|
9.6%
5/52 • Number of events 7
|
16.0%
8/50 • Number of events 9
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
9.6%
5/52 • Number of events 5
|
14.0%
7/50 • Number of events 13
|
|
Gastrointestinal disorders
Enteritis
|
5.8%
3/52 • Number of events 3
|
0.00%
0/50
|
|
Gastrointestinal disorders
Esophageal pain
|
5.8%
3/52 • Number of events 4
|
10.0%
5/50 • Number of events 5
|
|
Gastrointestinal disorders
Esophagitis
|
1.9%
1/52 • Number of events 1
|
4.0%
2/50 • Number of events 3
|
|
Gastrointestinal disorders
Flatulence
|
9.6%
5/52 • Number of events 8
|
2.0%
1/50 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/52
|
4.0%
2/50 • Number of events 2
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
7.7%
4/52 • Number of events 6
|
2.0%
1/50 • Number of events 1
|
|
Gastrointestinal disorders
Gingival pain
|
1.9%
1/52 • Number of events 2
|
2.0%
1/50 • Number of events 1
|
|
Gastrointestinal disorders
Hemorrhoids
|
13.5%
7/52 • Number of events 8
|
12.0%
6/50 • Number of events 7
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Gastrointestinal disorders
Mucositis oral
|
67.3%
35/52 • Number of events 52
|
70.0%
35/50 • Number of events 58
|
|
Gastrointestinal disorders
Nausea
|
90.4%
47/52 • Number of events 170
|
96.0%
48/50 • Number of events 170
|
|
Gastrointestinal disorders
Oesophagoscopy abnormal
|
0.00%
0/52
|
2.0%
1/50 • Number of events 2
|
|
Gastrointestinal disorders
Oral hemorrhage
|
3.8%
2/52 • Number of events 2
|
0.00%
0/50
|
|
Gastrointestinal disorders
Oral pain
|
1.9%
1/52 • Number of events 3
|
6.0%
3/50 • Number of events 4
|
|
Gastrointestinal disorders
Peritoneal pain
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Gastrointestinal disorders
Proctitis
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/52
|
4.0%
2/50 • Number of events 2
|
|
Gastrointestinal disorders
Rectal pain
|
3.8%
2/52 • Number of events 2
|
10.0%
5/50 • Number of events 6
|
|
Gastrointestinal disorders
Salivary gland disorder
|
1.9%
1/52 • Number of events 1
|
2.0%
1/50 • Number of events 1
|
|
Gastrointestinal disorders
Stomach pain
|
3.8%
2/52 • Number of events 2
|
4.0%
2/50 • Number of events 2
|
|
Gastrointestinal disorders
Toothache
|
1.9%
1/52 • Number of events 1
|
4.0%
2/50 • Number of events 2
|
|
Gastrointestinal disorders
Typhlitis
|
3.8%
2/52 • Number of events 2
|
2.0%
1/50 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
86.5%
45/52 • Number of events 103
|
88.0%
44/50 • Number of events 95
|
|
General disorders
Chest pain
|
7.7%
4/52 • Number of events 4
|
12.0%
6/50 • Number of events 7
|
|
General disorders
Chills
|
46.2%
24/52 • Number of events 36
|
50.0%
25/50 • Number of events 48
|
|
General disorders
Death NOS
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
|
General disorders
Edema limbs
|
30.8%
16/52 • Number of events 42
|
36.0%
18/50 • Number of events 36
|
|
General disorders
Facial pain
|
0.00%
0/52
|
2.0%
1/50 • Number of events 4
|
|
General disorders
Fatigue
|
84.6%
44/52 • Number of events 284
|
90.0%
45/50 • Number of events 257
|
|
General disorders
Fever
|
53.8%
28/52 • Number of events 47
|
52.0%
26/50 • Number of events 37
|
|
General disorders
Flu-like symptoms
|
3.8%
2/52 • Number of events 4
|
0.00%
0/50
|
|
General disorders
Gait abnormal
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
General disorders
General symptom
|
1.9%
1/52 • Number of events 1
|
2.0%
1/50 • Number of events 2
|
|
General disorders
Hypothermia
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
General disorders
Ill-defined disorder
|
1.9%
1/52 • Number of events 1
|
2.0%
1/50 • Number of events 1
|
|
General disorders
Localized edema
|
9.6%
5/52 • Number of events 5
|
10.0%
5/50 • Number of events 6
|
|
General disorders
Pain
|
26.9%
14/52 • Number of events 24
|
20.0%
10/50 • Number of events 15
|
|
General disorders
Radiation-Other(Specify,_____)
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
|
Hepatobiliary disorders
Hepatobiliary disease
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Immune system disorders
Cytokine release syndrome
|
11.5%
6/52 • Number of events 7
|
20.0%
10/50 • Number of events 13
|
|
Immune system disorders
Hypersensitivity
|
13.5%
7/52 • Number of events 11
|
22.0%
11/50 • Number of events 15
|
|
Immune system disorders
Serum sickness
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Infections and infestations
Abdominal infection
|
3.8%
2/52 • Number of events 2
|
2.0%
1/50 • Number of events 1
|
|
Infections and infestations
Anal infection
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
|
Infections and infestations
Anorectal infection
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
|
Infections and infestations
Arteritis infective
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
7.7%
4/52 • Number of events 5
|
0.00%
0/50
|
|
Infections and infestations
Catheter related infection
|
17.3%
9/52 • Number of events 12
|
24.0%
12/50 • Number of events 15
|
|
Infections and infestations
Colitis, infectious (e.g., Clostridium difficile)
|
3.8%
2/52 • Number of events 3
|
2.0%
1/50 • Number of events 2
|
|
Infections and infestations
Conjunctivitis infective
|
0.00%
0/52
|
4.0%
2/50 • Number of events 3
|
|
Infections and infestations
Gingival infection
|
5.8%
3/52 • Number of events 5
|
4.0%
2/50 • Number of events 2
|
|
Infections and infestations
Infection
|
7.7%
4/52 • Number of events 4
|
12.0%
6/50 • Number of events 9
|
|
Infections and infestations
Infection with grade 3 or 4 neutropenia
|
0.00%
0/52
|
4.0%
2/50 • Number of events 3
|
|
Infections and infestations
Infection without neutropenia
|
0.00%
0/52
|
4.0%
2/50 • Number of events 2
|
|
Infections and infestations
Infectious colitis
|
7.7%
4/52 • Number of events 4
|
4.0%
2/50 • Number of events 2
|
|
Infections and infestations
Lip infection
|
3.8%
2/52 • Number of events 2
|
2.0%
1/50 • Number of events 1
|
|
Infections and infestations
Mucosal infection
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Infections and infestations
Nail infection
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Infections and infestations
Opportunistic infection
|
0.00%
0/52
|
4.0%
2/50 • Number of events 2
|
|
Infections and infestations
Otitis externa
|
1.9%
1/52 • Number of events 2
|
0.00%
0/50
|
|
Infections and infestations
Otitis media
|
3.8%
2/52 • Number of events 2
|
0.00%
0/50
|
|
Infections and infestations
Pharyngitis
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Infections and infestations
Pneumonia
|
15.4%
8/52 • Number of events 12
|
10.0%
5/50 • Number of events 8
|
|
Infections and infestations
Rhinitis infective
|
5.8%
3/52 • Number of events 3
|
2.0%
1/50 • Number of events 1
|
|
Infections and infestations
Sepsis
|
13.5%
7/52 • Number of events 7
|
10.0%
5/50 • Number of events 6
|
|
Infections and infestations
Sinusitis
|
21.2%
11/52 • Number of events 11
|
12.0%
6/50 • Number of events 8
|
|
Infections and infestations
Skin infection
|
7.7%
4/52 • Number of events 4
|
14.0%
7/50 • Number of events 12
|
|
Infections and infestations
Tooth infection
|
1.9%
1/52 • Number of events 2
|
2.0%
1/50 • Number of events 1
|
|
Infections and infestations
Tracheitis
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Infections and infestations
Upper aerodigestive tract infection
|
1.9%
1/52 • Number of events 1
|
2.0%
1/50 • Number of events 1
|
|
Infections and infestations
Upper respiratory infection
|
26.9%
14/52 • Number of events 19
|
12.0%
6/50 • Number of events 6
|
|
Infections and infestations
Ureteritis
|
3.8%
2/52 • Number of events 3
|
4.0%
2/50 • Number of events 2
|
|
Infections and infestations
Urinary tract infection
|
9.6%
5/52 • Number of events 5
|
6.0%
3/50 • Number of events 6
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
|
Infections and infestations
Wound infection
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
|
Injury, poisoning and procedural complications
Bruising
|
5.8%
3/52 • Number of events 3
|
6.0%
3/50 • Number of events 3
|
|
Injury, poisoning and procedural complications
Fracture
|
1.9%
1/52 • Number of events 1
|
4.0%
2/50 • Number of events 2
|
|
Injury, poisoning and procedural complications
Gastrointestinal anastomotic leak
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Injury, poisoning and procedural complications
Intraoperative neurological injury - Spinal cord
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
5.8%
3/52 • Number of events 4
|
8.0%
4/50 • Number of events 4
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
|
Investigations
Activated partial thromboplastin time prolonged
|
11.5%
6/52 • Number of events 12
|
14.0%
7/50 • Number of events 9
|
|
Investigations
Alanine aminotransferase increased
|
50.0%
26/52 • Number of events 99
|
54.0%
27/50 • Number of events 86
|
|
Investigations
Alkaline phosphatase
|
1.9%
1/52 • Number of events 1
|
2.0%
1/50 • Number of events 1
|
|
Investigations
Alkaline phosphatase increased
|
32.7%
17/52 • Number of events 32
|
38.0%
19/50 • Number of events 56
|
|
Investigations
Aspartate aminotransferase increased
|
55.8%
29/52 • Number of events 92
|
62.0%
31/50 • Number of events 95
|
|
Investigations
Blood bilirubin increased
|
28.8%
15/52 • Number of events 33
|
32.0%
16/50 • Number of events 54
|
|
Investigations
CD4 lymphocytes decreased
|
1.9%
1/52 • Number of events 1
|
6.0%
3/50 • Number of events 3
|
|
Investigations
Cardiac troponin T increased
|
1.9%
1/52 • Number of events 1
|
2.0%
1/50 • Number of events 1
|
|
Investigations
Creatinine increased
|
21.2%
11/52 • Number of events 25
|
22.0%
11/50 • Number of events 27
|
|
Investigations
Fibrinogen decreased
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
|
Investigations
Gamma-glutamyltransferase increased
|
7.7%
4/52 • Number of events 11
|
2.0%
1/50 • Number of events 3
|
|
Investigations
INR increased
|
13.5%
7/52 • Number of events 13
|
10.0%
5/50 • Number of events 7
|
|
Investigations
Laboratory test abnormal
|
1.9%
1/52 • Number of events 2
|
4.0%
2/50 • Number of events 2
|
|
Investigations
Leukocyte count decreased
|
71.2%
37/52 • Number of events 261
|
76.0%
38/50 • Number of events 229
|
|
Investigations
Leukocytes (total WBC) for BMT studies, if specified in the protocol.
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
|
Investigations
Lymphocyte count decreased
|
67.3%
35/52 • Number of events 285
|
76.0%
38/50 • Number of events 264
|
|
Investigations
Neutrophil count decreased
|
100.0%
52/52 • Number of events 283
|
100.0%
50/50 • Number of events 300
|
|
Investigations
Platelet count decreased
|
100.0%
52/52 • Number of events 472
|
100.0%
50/50 • Number of events 399
|
|
Investigations
Serum cholesterol increased
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
|
Investigations
Weight gain
|
19.2%
10/52 • Number of events 15
|
18.0%
9/50 • Number of events 10
|
|
Investigations
Weight loss
|
19.2%
10/52 • Number of events 18
|
24.0%
12/50 • Number of events 15
|
|
Metabolism and nutrition disorders
Acidosis
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Metabolism and nutrition disorders
Anorexia
|
61.5%
32/52 • Number of events 55
|
70.0%
35/50 • Number of events 83
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
51.9%
27/52 • Number of events 217
|
46.0%
23/50 • Number of events 135
|
|
Metabolism and nutrition disorders
Blood uric acid increased
|
7.7%
4/52 • Number of events 4
|
6.0%
3/50 • Number of events 4
|
|
Metabolism and nutrition disorders
Dehydration
|
13.5%
7/52 • Number of events 8
|
16.0%
8/50 • Number of events 13
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
42.3%
22/52 • Number of events 57
|
46.0%
23/50 • Number of events 60
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
55.8%
29/52 • Number of events 126
|
50.0%
25/50 • Number of events 85
|
|
Metabolism and nutrition disorders
Serum calcium increased
|
5.8%
3/52 • Number of events 3
|
8.0%
4/50 • Number of events 8
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
17.3%
9/52 • Number of events 14
|
18.0%
9/50 • Number of events 17
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
28.8%
15/52 • Number of events 29
|
26.0%
13/50 • Number of events 28
|
|
Metabolism and nutrition disorders
Serum magnesium increased
|
11.5%
6/52 • Number of events 7
|
16.0%
8/50 • Number of events 12
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
28.8%
15/52 • Number of events 25
|
22.0%
11/50 • Number of events 20
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
53.8%
28/52 • Number of events 80
|
44.0%
22/50 • Number of events 67
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
7.7%
4/52 • Number of events 7
|
14.0%
7/50 • Number of events 10
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
46.2%
24/52 • Number of events 73
|
42.0%
21/50 • Number of events 71
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
19.2%
10/52 • Number of events 17
|
16.0%
8/50 • Number of events 10
|
|
Metabolism and nutrition disorders
Serum triglycerides increased
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
0.00%
0/52
|
4.0%
2/50 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
30.8%
16/52 • Number of events 48
|
30.0%
15/50 • Number of events 33
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
5.8%
3/52 • Number of events 13
|
4.0%
2/50 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
28.8%
15/52 • Number of events 36
|
26.0%
13/50 • Number of events 20
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
26.9%
14/52 • Number of events 25
|
16.0%
8/50 • Number of events 12
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
9.6%
5/52 • Number of events 6
|
8.0%
4/50 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
9.6%
5/52 • Number of events 15
|
24.0%
12/50 • Number of events 22
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/52
|
6.0%
3/50 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.00%
0/52
|
2.0%
1/50 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
13.5%
7/52 • Number of events 11
|
6.0%
3/50 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
21.2%
11/52 • Number of events 29
|
24.0%
12/50 • Number of events 28
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
13.5%
7/52 • Number of events 16
|
12.0%
6/50 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/52
|
2.0%
1/50 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/52
|
2.0%
1/50 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
30.8%
16/52 • Number of events 29
|
24.0%
12/50 • Number of events 19
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Nervous system disorders
Acoustic nerve disorder NOS
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Nervous system disorders
Ataxia
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
|
Nervous system disorders
Cognitive disturbance
|
3.8%
2/52 • Number of events 2
|
0.00%
0/50
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
30.8%
16/52 • Number of events 24
|
28.0%
14/50 • Number of events 17
|
|
Nervous system disorders
Dysgeusia
|
15.4%
8/52 • Number of events 12
|
18.0%
9/50 • Number of events 12
|
|
Nervous system disorders
Extrapyramidal disorder
|
5.8%
3/52 • Number of events 7
|
2.0%
1/50 • Number of events 1
|
|
Nervous system disorders
Facial muscle weakness
|
0.00%
0/52
|
4.0%
2/50 • Number of events 2
|
|
Nervous system disorders
Headache
|
61.5%
32/52 • Number of events 85
|
66.0%
33/50 • Number of events 56
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
|
Nervous system disorders
Ischemia cerebrovascular
|
3.8%
2/52 • Number of events 2
|
2.0%
1/50 • Number of events 1
|
|
Nervous system disorders
Memory impairment
|
13.5%
7/52 • Number of events 11
|
4.0%
2/50 • Number of events 4
|
|
Nervous system disorders
Neuralgia
|
11.5%
6/52 • Number of events 27
|
20.0%
10/50 • Number of events 26
|
|
Nervous system disorders
Neurological disorder NOS
|
7.7%
4/52 • Number of events 5
|
2.0%
1/50 • Number of events 3
|
|
Nervous system disorders
Nystagmus
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Nervous system disorders
Peripheral motor neuropathy
|
21.2%
11/52 • Number of events 37
|
8.0%
4/50 • Number of events 11
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
73.1%
38/52 • Number of events 243
|
84.0%
42/50 • Number of events 216
|
|
Nervous system disorders
Phrenic nerve paralysis
|
0.00%
0/52
|
4.0%
2/50 • Number of events 4
|
|
Nervous system disorders
Radiculitis brachial
|
0.00%
0/52
|
4.0%
2/50 • Number of events 4
|
|
Nervous system disorders
Seizure
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
|
Nervous system disorders
Sinus pain
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
|
Nervous system disorders
Syncope
|
11.5%
6/52 • Number of events 7
|
4.0%
2/50 • Number of events 4
|
|
Nervous system disorders
Syncope vasovagal
|
0.00%
0/52
|
4.0%
2/50 • Number of events 2
|
|
Nervous system disorders
Tremor
|
3.8%
2/52 • Number of events 2
|
8.0%
4/50 • Number of events 5
|
|
Psychiatric disorders
Agitation
|
0.00%
0/52
|
2.0%
1/50 • Number of events 3
|
|
Psychiatric disorders
Anxiety
|
25.0%
13/52 • Number of events 38
|
28.0%
14/50 • Number of events 24
|
|
Psychiatric disorders
Confusion
|
1.9%
1/52 • Number of events 1
|
8.0%
4/50 • Number of events 7
|
|
Psychiatric disorders
Depression
|
5.8%
3/52 • Number of events 4
|
20.0%
10/50 • Number of events 17
|
|
Psychiatric disorders
Insomnia
|
36.5%
19/52 • Number of events 50
|
58.0%
29/50 • Number of events 74
|
|
Psychiatric disorders
Libido decreased
|
1.9%
1/52 • Number of events 1
|
2.0%
1/50 • Number of events 1
|
|
Psychiatric disorders
Psychosis
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
|
Renal and urinary disorders
Bladder hemorrhage
|
1.9%
1/52 • Number of events 1
|
4.0%
2/50 • Number of events 2
|
|
Renal and urinary disorders
Bladder pain
|
1.9%
1/52 • Number of events 1
|
2.0%
1/50 • Number of events 1
|
|
Renal and urinary disorders
Glomerular filtration rate decreased
|
3.8%
2/52 • Number of events 2
|
0.00%
0/50
|
|
Renal and urinary disorders
Hemoglobin urine positive
|
1.9%
1/52 • Number of events 2
|
0.00%
0/50
|
|
Renal and urinary disorders
Proteinuria
|
3.8%
2/52 • Number of events 3
|
2.0%
1/50 • Number of events 1
|
|
Renal and urinary disorders
Urethral pain
|
1.9%
1/52 • Number of events 2
|
2.0%
1/50 • Number of events 1
|
|
Renal and urinary disorders
Urinary frequency
|
1.9%
1/52 • Number of events 1
|
16.0%
8/50 • Number of events 10
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/52
|
4.0%
2/50 • Number of events 3
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/52
|
8.0%
4/50 • Number of events 5
|
|
Renal and urinary disorders
Urine discoloration
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Renal and urinary disorders
Urogenital disorder
|
5.8%
3/52 • Number of events 7
|
2.0%
1/50 • Number of events 3
|
|
Reproductive system and breast disorders
Breast pain
|
3.8%
2/52 • Number of events 2
|
2.0%
1/50 • Number of events 2
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
3.8%
2/52 • Number of events 2
|
2.0%
1/50 • Number of events 1
|
|
Reproductive system and breast disorders
Gynecomastia
|
0.00%
0/52
|
4.0%
2/50 • Number of events 2
|
|
Reproductive system and breast disorders
Pelvic floor muscle weakness
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Reproductive system and breast disorders
Pelvic pain
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Reproductive system and breast disorders
Scrotal pain
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
|
Reproductive system and breast disorders
Testicular pain
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
32.7%
17/52 • Number of events 30
|
20.0%
10/50 • Number of events 15
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
0.00%
0/52
|
4.0%
2/50 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
1.9%
1/52 • Number of events 1
|
2.0%
1/50 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
57.7%
30/52 • Number of events 64
|
36.0%
18/50 • Number of events 33
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
42.3%
22/52 • Number of events 53
|
38.0%
19/50 • Number of events 55
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.6%
5/52 • Number of events 6
|
22.0%
11/50 • Number of events 14
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
7.7%
4/52 • Number of events 5
|
6.0%
3/50 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.8%
2/52 • Number of events 2
|
4.0%
2/50 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.9%
1/52 • Number of events 1
|
2.0%
1/50 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
5.8%
3/52 • Number of events 3
|
20.0%
10/50 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.8%
2/52 • Number of events 6
|
2.0%
1/50 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.8%
3/52 • Number of events 5
|
24.0%
12/50 • Number of events 22
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
11.5%
6/52 • Number of events 6
|
2.0%
1/50 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
3.8%
2/52 • Number of events 4
|
4.0%
2/50 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
36.5%
19/52 • Number of events 30
|
10.0%
5/50 • Number of events 10
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
9.6%
5/52 • Number of events 5
|
8.0%
4/50 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
3.8%
2/52 • Number of events 2
|
4.0%
2/50 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
0.00%
0/52
|
4.0%
2/50 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
3.8%
2/52 • Number of events 2
|
2.0%
1/50 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
7.7%
4/52 • Number of events 8
|
4.0%
2/50 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
5.8%
3/52 • Number of events 3
|
10.0%
5/50 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
17.3%
9/52 • Number of events 14
|
18.0%
9/50 • Number of events 12
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
3.8%
2/52 • Number of events 3
|
0.00%
0/50
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
65.4%
34/52 • Number of events 62
|
62.0%
31/50 • Number of events 73
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
13.5%
7/52 • Number of events 10
|
14.0%
7/50 • Number of events 11
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
0.00%
0/52
|
2.0%
1/50 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Sweating
|
21.2%
11/52 • Number of events 23
|
24.0%
12/50 • Number of events 17
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
3.8%
2/52 • Number of events 3
|
4.0%
2/50 • Number of events 3
|
|
Vascular disorders
Flushing
|
13.5%
7/52 • Number of events 8
|
14.0%
7/50 • Number of events 8
|
|
Vascular disorders
Hemorrhage
|
3.8%
2/52 • Number of events 2
|
2.0%
1/50 • Number of events 1
|
|
Vascular disorders
Hot flashes
|
0.00%
0/52
|
4.0%
2/50 • Number of events 2
|
|
Vascular disorders
Hypertension
|
9.6%
5/52 • Number of events 12
|
24.0%
12/50 • Number of events 15
|
|
Vascular disorders
Hypotension
|
25.0%
13/52 • Number of events 18
|
30.0%
15/50 • Number of events 19
|
|
Vascular disorders
Phlebitis
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Vascular disorders
Thrombosis
|
9.6%
5/52 • Number of events 6
|
2.0%
1/50 • Number of events 1
|
|
Vascular disorders
Vasculitis
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60